Cataract
Conditions
Brief summary
The purpose of this study is to determine whether the use of OMS302 (the study drug) in individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and effective at maintaining an adequately dilated pupil during surgery and reducing post-operative symptoms of discomfort (such as eye pain and irritation).
Interventions
DRUGOMS302 Solution
DRUGOMS302 Mydriatic Solution
DRUGOMS302 Anti-inflammatory Solution
DRUGBalanced Salt Solution (BSS) Solution
Sponsors
Omeros Corporation
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Competent and willing to voluntarily provide informed consent * 18 years of age or older * In good general health needing to undergo cataract extraction with lens replacement surgery in one eye, under topical anesthesia * Other inclusion criteria to be evaluated by the investigator
Exclusion criteria
* No allergies to the medications and/or the active ingredients of any of the study medications * No medications with the same activities as the of the active ingredients in OMS302 for defined time intervals prior to and after surgery * No other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pupil Diameter (mm) During Surgery | During surgery (immediately prior to surgical incision to wound closure) | Pupil diameter from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment group and time point. Repeated measures analyses of variance were used to test for differences in the maintenance of mydriasis. The repeated measures model included change from baseline pupil diameter as the response variable and treatment (OMS302, ketorolac tromethamine, and vehicle), time point (as a categorical variable) and the stratification factor lens opacities classification system II (LOCS II) grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working-correlation structure was used. |
| Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | through 12 hours post-surgery | For the primary analysis of this endpoint, only the results on the day of operation at 2, 4, 6, 8 and 10-12 hours were utilized. The VAS scores (where 0 = no pain and 100 = worst possible pain) were summarized by treatment group and time point. Repeated measures analyses of variance were used to test for differences in postoperative ocular pain. The repeated measures model included VAS pain score as the response variable and treatment (OMS302, phenylephrine hydrochloride (PE), and vehicle), time point (as a categorical variable) and the stratification factor LOCS II grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working correlation structure was used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery | One day | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery | Two days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery | Seven days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery | 14 days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination | up to 30 days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery | Two hours | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery | Six hours | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery | One day | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery | Two days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery | Seven days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery | 14 days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination | Up to 30 days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery | Two hours | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery | Six hours | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery | One day | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery | Two days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery | Seven days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery | 14 days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination | Up to 30 days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery | Two hours | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery | Six hours | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery | One day | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery | Two days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery | Seven days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery | 14 days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination | Up to 30 days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery | Two hours | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination | Up to 30 days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery | Six hours | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery | One day | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery | Two days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days | Seven days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery | 14 days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery | Two hours | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery | Six hours | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery | One day | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery | Two days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery | Seven days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery | 14 days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination | Up to 30 days | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Best Corrected Visual Acuity (BVCA) - Log Score, Baseline | Baseline | Best-Corrected Visual Acuity (BCVA) was summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests. |
| Best Corrected Visual Acuity (BVCA) - Log Score, Day 1 | One day | Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests. |
| Best Corrected Visual Acuity (BVCA) - Log Score, Day 2 | Two days | Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests. |
| Best Corrected Visual Acuity (BVCA) - Log Score, Day 7 | Seven days | Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests. |
| Best Corrected Visual Acuity (BVCA) - Log Score, Day 14 | 14 days | Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests. |
| Best Corrected Visual Acuity (BVCA) - Log Score, Day 30 | 30 days | Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests. |
| Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Baseline | Baseline | Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous |
| Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, 2 Hours Post Surgery | Two hours | TPostoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous |
| Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 1 | One day | Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous |
| Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 2 | Two days | Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous |
| Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 7 | Seven days | Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous |
| Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 14 | 14 days | Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous |
| Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 30 | 30 days | Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous |
| Subjects With Postoperative Ocular Inflammation SOIS = 0, Baseline | Baseline | Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous |
| Subjects With Postoperative Ocular Inflammation SOIS = 0, Two Hours Post-surgery | Two hours | Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous |
| Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 1 | One day | Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous |
| Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 2 | Two days | Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous |
| Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 7 | Seven days | Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous |
| Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 14 | 14 days | Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous |
| Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 30 | 30 days | Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous |
| Postoperative Mean Anterior Chamber Cell Count, Two Hours Post-Surgery | Two hours | The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as \> 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests. |
| Postoperative Mean Anterior Chamber Cell Count, Day 1 | One day | The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as \> 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests. |
| Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery | Two hours | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Postoperative Mean Anterior Chamber Cell Count, Day 7 | Seven days | The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as \> 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests. |
| Postoperative Mean Anterior Chamber Cell Count, Day 14 | 14 days | The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as \> 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests. |
| Postoperative Mean Anterior Chamber Cell Count, Day 30 | 30 days | The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as \> 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests. |
| Ocular Pain VAS Score After Day 0 | 43 days | VAS pain scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery were summarized. |
| Postoperative Use of Ophthalmic Anti-inflammatory Medications | up to 30 days | Ophthalmic anti-inflammatory medications were identified by reviewing concomitant medications. Subject incidence of ophthalmic anti-inflammatory medication use by post-surgery day was presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Use of Pain Medications at Day 1 | One day | Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Use of Pain Medications After Day 1 | up to 30 days | Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
| Postoperative Mean Anterior Chamber Cell Count, Day 2 | Two days | The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as \> 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests. |
| Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery | Six hours | The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)
Balanced Salt Solution (BSS) | 57 |
| OMS302 Mydriatic Solution (PE) OMS302 Mydriatic Solution
OMS302 Mydriatic Solution | 54 |
| OMS302 Anti-inflammatory Solution (KE) OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution | 55 |
| OMS302 Solution OMS302 Solution
OMS302 Solution | 56 |
| Total | 222 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Randomized | Surgery Cancelled | 0 | 0 | 0 | 1 |
| Treated | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Balanced Salt Solution (BSS) | OMS302 Mydriatic Solution (PE) | OMS302 Anti-inflammatory Solution (KE) | OMS302 Solution | Total |
|---|---|---|---|---|---|
| Age, Continuous | 68.5 years STANDARD_DEVIATION 9.6 | 67.6 years STANDARD_DEVIATION 10.6 | 66.8 years STANDARD_DEVIATION 8.6 | 66.4 years STANDARD_DEVIATION 11.2 | 67.3 years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 33 Participants | 34 Participants | 33 Participants | 37 Participants | 137 Participants |
| Sex: Female, Male Male | 24 Participants | 20 Participants | 22 Participants | 19 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 45 / 57 | 43 / 54 | 37 / 55 | 47 / 56 |
| serious Total, serious adverse events | 0 / 57 | 1 / 54 | 0 / 55 | 0 / 56 |
Outcome results
Primary
Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively
For the primary analysis of this endpoint, only the results on the day of operation at 2, 4, 6, 8 and 10-12 hours were utilized. The VAS scores (where 0 = no pain and 100 = worst possible pain) were summarized by treatment group and time point. Repeated measures analyses of variance were used to test for differences in postoperative ocular pain. The repeated measures model included VAS pain score as the response variable and treatment (OMS302, phenylephrine hydrochloride (PE), and vehicle), time point (as a categorical variable) and the stratification factor LOCS II grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working correlation structure was used.
Time frame: through 12 hours post-surgery
Population: Subjects with postoperative VAS scores.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 8 hours post-surgery | 8.9 units on a scale | Standard Deviation 14.7 |
| Balanced Salt Solution (BSS) | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 4 hours post-surgery | 10.9 units on a scale | Standard Deviation 19.3 |
| Balanced Salt Solution (BSS) | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 10-12 hours post-surgery | 10.3 units on a scale | Standard Deviation 18.3 |
| Balanced Salt Solution (BSS) | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 6 hours post-surgery | 10.5 units on a scale | Standard Deviation 17.2 |
| Balanced Salt Solution (BSS) | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 2 hours post-surgery | 8.6 units on a scale | Standard Deviation 14.7 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 6 hours post-surgery | 9.5 units on a scale | Standard Deviation 14.9 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 8 hours post-surgery | 12.2 units on a scale | Standard Deviation 16.9 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 10-12 hours post-surgery | 11.8 units on a scale | Standard Deviation 17.1 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 4 hours post-surgery | 10.5 units on a scale | Standard Deviation 16.9 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 2 hours post-surgery | 9.4 units on a scale | Standard Deviation 16.8 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 6 hours post-surgery | 4.3 units on a scale | Standard Deviation 10.9 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 2 hours post-surgery | 4.1 units on a scale | Standard Deviation 12.7 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 4 hours post-surgery | 4.8 units on a scale | Standard Deviation 12.3 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 8 hours post-surgery | 4.0 units on a scale | Standard Deviation 11 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 10-12 hours post-surgery | 3.4 units on a scale | Standard Deviation 9.2 |
| OMS302 Solution | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 8 hours post-surgery | 4.0 units on a scale | Standard Deviation 10.5 |
| OMS302 Solution | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 4 hours post-surgery | 5.9 units on a scale | Standard Deviation 12.4 |
| OMS302 Solution | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 2 hours post-surgery | 5.3 units on a scale | Standard Deviation 11.8 |
| OMS302 Solution | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 6 hours post-surgery | 3.9 units on a scale | Standard Deviation 8.6 |
| OMS302 Solution | Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively | 10-12 hours post-surgery | 4.7 units on a scale | Standard Deviation 13.4 |
p-value: 0.042195% CI: [-8.9, -0.2]repeated measures model
p-value: 0.009395% CI: [-10.3, -1.5]repeated measures model
Primary
Pupil Diameter (mm) During Surgery
Pupil diameter from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment group and time point. Repeated measures analyses of variance were used to test for differences in the maintenance of mydriasis. The repeated measures model included change from baseline pupil diameter as the response variable and treatment (OMS302, ketorolac tromethamine, and vehicle), time point (as a categorical variable) and the stratification factor lens opacities classification system II (LOCS II) grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working-correlation structure was used.
Time frame: During surgery (immediately prior to surgical incision to wound closure)
Population: Subjects with interpretable video recordings obtained during surgery.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 30 minutes; n = 1, 0, 0, 0 | 4.1 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 16 minutes; n = 7, 6, 7, 6 | 5.8 mm | Standard Deviation 1.9 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 17 minutes; n = 7, 5, 6, 5 | 5.6 mm | Standard Deviation 1.8 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 4 minutes; n = 52, 49, 52, 49 | 7.6 mm | Standard Deviation 2 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 22 minutes; n = 1, 2, 0, 2 | 2.3 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 18 minutes; n = 6, 3, 5, 5 | 5.4 mm | Standard Deviation 1.6 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 23 minutes; n = 1, 1, 0, 2 | 3.0 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 19 minutes; n = 3, 3, 4, 5 | 5.2 mm | Standard Deviation 2.1 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 21 minutes; n = 2, 2, 0, 3 | 4.9 mm | Standard Deviation 3.3 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 20 minutes; n = 2, 2, 2, 3 | 5.2 mm | Standard Deviation 3.2 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 29 minutes; n = 1, 0, 0, 1 | 3.4 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 5 minutes; n = 52, 49, 51, 48 | 7.5 mm | Standard Deviation 2.3 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 1 minute; n = 53, 48, 52, 48 | 8.2 mm | Standard Deviation 2.1 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 6 minutes; n = 51, 45, 50, 48 | 7.4 mm | Standard Deviation 2.6 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 28 minutes; n = 1, 0, 0, 1 | 3.6 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 7 minutes; n = 45, 37, 44, 43 | 7.1 mm | Standard Deviation 2.7 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | Baseline; n = 53, 49, 52, 49 | 8.0 mm | Standard Deviation 2 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 8 minutes; n = 34, 28, 40, 36 | 7.1 mm | Standard Deviation 2.7 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 31 minutes; n = 1, 0, 0, 0 | 3.2 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 27 minutes; n = 1, 0, 0, 1 | 3.3 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 9 minutes; n = 27, 25, 32, 32 | 7.3 mm | Standard Deviation 3 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 2 minutes; n = 53, 49, 52, 49 | 8.0 mm | Standard Deviation 2 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 10 minutes; n = 26, 19, 25, 28 | 7.1 mm | Standard Deviation 2.5 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 26 minutes; n = 1, 0, 0, 1 | 3.1 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 11 minutes; n = 24, 18, 22, 27 | 7.0 mm | Standard Deviation 2.9 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 12 minutes; n = 22, 17, 20, 23 | 6.9 mm | Standard Deviation 3 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 25 minutes; n = 1, 1, 0, 2 | 2.6 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 13 minutes; n = 14, 13, 16, 17 | 6.2 mm | Standard Deviation 1.6 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 3 minutes; n = 53, 49, 52, 49 | 7.9 mm | Standard Deviation 2.2 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 14 minutes; n = 10, 8, 13, 10 | 6.3 mm | Standard Deviation 1.8 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 24 minutes; n = 1, 1, 0, 2 | 4.2 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Pupil Diameter (mm) During Surgery | 15 minutes; n = 8, 7, 8, 9 | 6.1 mm | Standard Deviation 1.6 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | Baseline; n = 53, 49, 52, 49 | 8.0 mm | Standard Deviation 1.8 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 23 minutes; n = 1, 1, 0, 2 | 6.6 mm | Standard Deviation 0 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 27 minutes; n = 1, 0, 0, 1 | NA mm | — |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 16 minutes; n = 7, 6, 7, 6 | 8.4 mm | Standard Deviation 3 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 29 minutes; n = 1, 0, 0, 1 | NA mm | — |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 22 minutes; n = 1, 2, 0, 2 | 7.5 mm | Standard Deviation 1.5 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 25 minutes; n = 1, 1, 0, 2 | 6.4 mm | Standard Deviation 0 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 17 minutes; n = 7, 5, 6, 5 | 7.2 mm | Standard Deviation 1.4 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 8 minutes; n = 34, 28, 40, 36 | 7.8 mm | Standard Deviation 2.5 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 24 minutes; n = 1, 1, 0, 2 | 7.1 mm | Standard Deviation 0 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 12 minutes; n = 22, 17, 20, 23 | 8.0 mm | Standard Deviation 2.7 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 18 minutes; n = 6, 3, 5, 5 | 7.9 mm | Standard Deviation 0.9 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 4 minutes; n = 52, 49, 52, 49 | 8.4 mm | Standard Deviation 1.8 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 30 minutes; n = 1, 0, 0, 0 | NA mm | — |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 21 minutes; n = 2, 2, 0, 3 | 8.0 mm | Standard Deviation 1.5 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 9 minutes; n = 27, 25, 32, 32 | 8.1 mm | Standard Deviation 2.6 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 19 minutes; n = 3, 3, 4, 5 | 7.8 mm | Standard Deviation 1 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 31 minutes; n = 1, 0, 0, 0 | NA mm | — |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 15 minutes; n = 8, 7, 8, 9 | 7.9 mm | Standard Deviation 2.7 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 26 minutes; n = 1, 0, 0, 1 | NA mm | — |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 20 minutes; n = 2, 2, 2, 3 | 8.1 mm | Standard Deviation 1.4 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 14 minutes; n = 10, 8, 13, 10 | 7.7 mm | Standard Deviation 2.8 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 10 minutes; n = 26, 19, 25, 28 | 8.3 mm | Standard Deviation 2.8 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 5 minutes; n = 52, 49, 51, 48 | 8.2 mm | Standard Deviation 1.9 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 2 minutes; n = 53, 49, 52, 49 | 8.3 mm | Standard Deviation 1.7 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 28 minutes; n = 1, 0, 0, 1 | NA mm | — |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 13 minutes; n = 14, 13, 16, 17 | 8.0 mm | Standard Deviation 2.9 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 6 minutes; n = 51, 45, 50, 48 | 8.1 mm | Standard Deviation 2 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 1 minute; n = 53, 48, 52, 48 | 8.3 mm | Standard Deviation 1.9 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 3 minutes; n = 53, 49, 52, 49 | 8.4 mm | Standard Deviation 1.8 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 11 minutes; n = 24, 18, 22, 27 | 8.3 mm | Standard Deviation 2.7 |
| OMS302 Mydriatic Solution (PE) | Pupil Diameter (mm) During Surgery | 7 minutes; n = 45, 37, 44, 43 | 8.0 mm | Standard Deviation 2.3 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 27 minutes; n = 1, 0, 0, 1 | NA mm | — |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | Baseline; n = 53, 49, 52, 49 | 8.1 mm | Standard Deviation 1.6 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 1 minute; n = 53, 48, 52, 48 | 8.3 mm | Standard Deviation 1.6 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 2 minutes; n = 53, 49, 52, 49 | 8.2 mm | Standard Deviation 1.8 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 3 minutes; n = 53, 49, 52, 49 | 8.1 mm | Standard Deviation 1.7 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 4 minutes; n = 52, 49, 52, 49 | 7.9 mm | Standard Deviation 1.8 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 5 minutes; n = 52, 49, 51, 48 | 7.9 mm | Standard Deviation 1.9 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 6 minutes; n = 51, 45, 50, 48 | 7.7 mm | Standard Deviation 1.8 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 7 minutes; n = 45, 37, 44, 43 | 7.2 mm | Standard Deviation 2 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 8 minutes; n = 34, 28, 40, 36 | 7.1 mm | Standard Deviation 2.1 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 9 minutes; n = 27, 25, 32, 32 | 7.0 mm | Standard Deviation 1.9 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 10 minutes; n = 26, 19, 25, 28 | 7.0 mm | Standard Deviation 1.5 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 11 minutes; n = 24, 18, 22, 27 | 7.1 mm | Standard Deviation 1.4 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 12 minutes; n = 22, 17, 20, 23 | 7.0 mm | Standard Deviation 1.1 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 13 minutes; n = 14, 13, 16, 17 | 6.8 mm | Standard Deviation 1.4 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 14 minutes; n = 10, 8, 13, 10 | 6.5 mm | Standard Deviation 1.4 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 15 minutes; n = 8, 7, 8, 9 | 6.9 mm | Standard Deviation 2.1 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 16 minutes; n = 7, 6, 7, 6 | 6.7 mm | Standard Deviation 1.6 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 17 minutes; n = 7, 5, 6, 5 | 6.8 mm | Standard Deviation 1.7 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 18 minutes; n = 6, 3, 5, 5 | 6.8 mm | Standard Deviation 3.1 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 19 minutes; n = 3, 3, 4, 5 | 6.7 mm | Standard Deviation 3.9 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 20 minutes; n = 2, 2, 2, 3 | 5.2 mm | Standard Deviation 0.9 |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 21 minutes; n = 2, 2, 0, 3 | NA mm | — |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 22 minutes; n = 1, 2, 0, 2 | NA mm | — |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 23 minutes; n = 1, 1, 0, 2 | NA mm | — |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 24 minutes; n = 1, 1, 0, 2 | NA mm | — |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 25 minutes; n = 1, 1, 0, 2 | NA mm | — |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 26 minutes; n = 1, 0, 0, 1 | NA mm | — |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 28 minutes; n = 1, 0, 0, 1 | NA mm | — |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 29 minutes; n = 1, 0, 0, 1 | NA mm | — |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 30 minutes; n = 1, 0, 0, 0 | NA mm | — |
| OMS302 Anti-inflammatory Solution (KE) | Pupil Diameter (mm) During Surgery | 31 minutes; n = 1, 0, 0, 0 | NA mm | — |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 29 minutes; n = 1, 0, 0, 1 | 18.7 mm | Standard Deviation 0 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 23 minutes; n = 1, 1, 0, 2 | 14.6 mm | Standard Deviation 7.1 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 14 minutes; n = 10, 8, 13, 10 | 9.5 mm | Standard Deviation 3 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 13 minutes; n = 14, 13, 16, 17 | 8.7 mm | Standard Deviation 3.3 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 2 minutes; n = 53, 49, 52, 49 | 9.2 mm | Standard Deviation 3.2 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 24 minutes; n = 1, 1, 0, 2 | 13.0 mm | Standard Deviation 5.7 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 12 minutes; n = 22, 17, 20, 23 | 9.2 mm | Standard Deviation 3.8 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 11 minutes; n = 24, 18, 22, 27 | 8.8 mm | Standard Deviation 3.2 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 31 minutes; n = 1, 0, 0, 0 | NA mm | — |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 10 minutes; n = 26, 19, 25, 28 | 8.8 mm | Standard Deviation 3.2 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 9 minutes; n = 27, 25, 32, 32 | 8.9 mm | Standard Deviation 3 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 30 minutes; n = 1, 0, 0, 0 | NA mm | — |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 26 minutes; n = 1, 0, 0, 1 | 17.2 mm | Standard Deviation 0 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 8 minutes; n = 34, 28, 40, 36 | 8.7 mm | Standard Deviation 3 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 7 minutes; n = 45, 37, 44, 43 | 9.0 mm | Standard Deviation 3.1 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 25 minutes; n = 1, 1, 0, 2 | 13.9 mm | Standard Deviation 5.9 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 27 minutes; n = 1, 0, 0, 1 | 17.4 mm | Standard Deviation 0 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 6 minutes; n = 51, 45, 50, 48 | 9.1 mm | Standard Deviation 3.1 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 5 minutes; n = 52, 49, 51, 48 | 9.1 mm | Standard Deviation 2.8 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 1 minute; n = 53, 48, 52, 48 | 9.4 mm | Standard Deviation 3.1 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 28 minutes; n = 1, 0, 0, 1 | 17.1 mm | Standard Deviation 0 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 4 minutes; n = 52, 49, 52, 49 | 9.4 mm | Standard Deviation 3.1 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 20 minutes; n = 2, 2, 2, 3 | 12.4 mm | Standard Deviation 6.3 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 19 minutes; n = 3, 3, 4, 5 | 11.5 mm | Standard Deviation 5 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 18 minutes; n = 6, 3, 5, 5 | 12.0 mm | Standard Deviation 5.6 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 3 minutes; n = 53, 49, 52, 49 | 9.2 mm | Standard Deviation 3.1 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 21 minutes; n = 2, 2, 0, 3 | 12.0 mm | Standard Deviation 5.8 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 17 minutes; n = 7, 5, 6, 5 | 12.0 mm | Standard Deviation 5.1 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 16 minutes; n = 7, 6, 7, 6 | 10.4 mm | Standard Deviation 4.8 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | Baseline; n = 53, 49, 52, 49 | 9.0 mm | Standard Deviation 2.9 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 22 minutes; n = 1, 2, 0, 2 | 14.6 mm | Standard Deviation 7.6 |
| OMS302 Solution | Pupil Diameter (mm) During Surgery | 15 minutes; n = 8, 7, 8, 9 | 9.9 mm | Standard Deviation 3.7 |
p-value: 095% CI: [0.6, 1.1]repeated measures model
p-value: 095% CI: [0.5, 0.9]repeated measures model
Secondary
Best Corrected Visual Acuity (BVCA) - Log Score, Baseline
Best-Corrected Visual Acuity (BCVA) was summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.
Time frame: Baseline
Population: Subjects with scores at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Best Corrected Visual Acuity (BVCA) - Log Score, Baseline | 0.4 Log score | Standard Deviation 0.3 |
| OMS302 Mydriatic Solution (PE) | Best Corrected Visual Acuity (BVCA) - Log Score, Baseline | 0.4 Log score | Standard Deviation 0.2 |
| OMS302 Anti-inflammatory Solution (KE) | Best Corrected Visual Acuity (BVCA) - Log Score, Baseline | 0.4 Log score | Standard Deviation 0.2 |
| OMS302 Solution | Best Corrected Visual Acuity (BVCA) - Log Score, Baseline | 0.4 Log score | Standard Deviation 0.3 |
p-value: 0.172Wilcoxon rank-sum test
p-value: 0.547Wilcoxon rank-sum test
p-value: 0.921Wicoxon rank-sum test
Secondary
Best Corrected Visual Acuity (BVCA) - Log Score, Day 1
Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.
Time frame: One day
Population: Subjects with scores at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Best Corrected Visual Acuity (BVCA) - Log Score, Day 1 | 0.1 Log score | Standard Deviation 0.2 |
| OMS302 Mydriatic Solution (PE) | Best Corrected Visual Acuity (BVCA) - Log Score, Day 1 | 0.2 Log score | Standard Deviation 0.3 |
| OMS302 Anti-inflammatory Solution (KE) | Best Corrected Visual Acuity (BVCA) - Log Score, Day 1 | 0.2 Log score | Standard Deviation 0.2 |
| OMS302 Solution | Best Corrected Visual Acuity (BVCA) - Log Score, Day 1 | 0.1 Log score | Standard Deviation 0.2 |
p-value: 0.701Wilcoxon rank-sum test
p-value: 0.089Wilcoxon rank-sum test
p-value: 0.095Wilcoxon rank-sum test
Secondary
Best Corrected Visual Acuity (BVCA) - Log Score, Day 14
Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.
Time frame: 14 days
Population: Subjects with scores at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Best Corrected Visual Acuity (BVCA) - Log Score, Day 14 | 0.1 Log score | Standard Deviation 0.2 |
| OMS302 Mydriatic Solution (PE) | Best Corrected Visual Acuity (BVCA) - Log Score, Day 14 | 0.1 Log score | Standard Deviation 0.2 |
| OMS302 Anti-inflammatory Solution (KE) | Best Corrected Visual Acuity (BVCA) - Log Score, Day 14 | 0.1 Log score | Standard Deviation 0.2 |
| OMS302 Solution | Best Corrected Visual Acuity (BVCA) - Log Score, Day 14 | 0.1 Log score | Standard Deviation 0.1 |
p-value: 0.22Wilcoxon rank-sum test
p-value: 0.903Wilcoxon rank-sum test
p-value: 0.463Wilcoxon rank-sum test
Secondary
Best Corrected Visual Acuity (BVCA) - Log Score, Day 2
Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.
Time frame: Two days
Population: Subjects with scores at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Best Corrected Visual Acuity (BVCA) - Log Score, Day 2 | 0.1 Log score | Standard Deviation 0.2 |
| OMS302 Mydriatic Solution (PE) | Best Corrected Visual Acuity (BVCA) - Log Score, Day 2 | 0.2 Log score | Standard Deviation 0.3 |
| OMS302 Anti-inflammatory Solution (KE) | Best Corrected Visual Acuity (BVCA) - Log Score, Day 2 | 0.1 Log score | Standard Deviation 0.2 |
| OMS302 Solution | Best Corrected Visual Acuity (BVCA) - Log Score, Day 2 | 0.1 Log score | Standard Deviation 0.1 |
p-value: 0.086Wilcoxon rank-sum test
p-value: 0.092Wicoxon rank-sum test
p-value: 0.12Wilcoxon rank-sum test
Secondary
Best Corrected Visual Acuity (BVCA) - Log Score, Day 30
Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.
Time frame: 30 days
Population: Subjects with scores at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Best Corrected Visual Acuity (BVCA) - Log Score, Day 30 | 0.1 Log score | Standard Deviation 0.2 |
| OMS302 Mydriatic Solution (PE) | Best Corrected Visual Acuity (BVCA) - Log Score, Day 30 | 0.1 Log score | Standard Deviation 0.2 |
| OMS302 Anti-inflammatory Solution (KE) | Best Corrected Visual Acuity (BVCA) - Log Score, Day 30 | 0.1 Log score | Standard Deviation 0.2 |
| OMS302 Solution | Best Corrected Visual Acuity (BVCA) - Log Score, Day 30 | 0.1 Log score | Standard Deviation 0.1 |
p-value: 0.675Wilcoxon rank-sum test
p-value: 0.825WIlcoxon rank-sum test
p-value: 0.668Wilcoxon rank-sum test
Secondary
Best Corrected Visual Acuity (BVCA) - Log Score, Day 7
Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.
Time frame: Seven days
Population: Subjects with scores at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Best Corrected Visual Acuity (BVCA) - Log Score, Day 7 | 0.1 Log score | Standard Deviation 0.2 |
| OMS302 Mydriatic Solution (PE) | Best Corrected Visual Acuity (BVCA) - Log Score, Day 7 | 0.1 Log score | Standard Deviation 0.2 |
| OMS302 Anti-inflammatory Solution (KE) | Best Corrected Visual Acuity (BVCA) - Log Score, Day 7 | 0.1 Log score | Standard Deviation 0.1 |
| OMS302 Solution | Best Corrected Visual Acuity (BVCA) - Log Score, Day 7 | 0.1 Log score | Standard Deviation 0.2 |
p-value: 0.626Wilcoxon rank-sum test
p-value: 0.736Wilcoxon rank-sum test
p-value: 0.725Wilcoxon rank-sum test
Secondary
Ocular Pain VAS Score After Day 0
VAS pain scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery were summarized.
Time frame: 43 days
Population: Subjects with data at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 1 AM; n = 55, 54, 55, 55 | 13.4 mm | Standard Deviation 21.7 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 27; n = 9, 9, 6, 5 | 0.6 mm | Standard Deviation 1.7 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 15; 22, 25, 18, 14 | 2.1 mm | Standard Deviation 3.6 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 31; n = 2, 2, 1, 3 | 0.0 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 16; 1, 7, 2, 5 | 0.0 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 26; n = 0, 1, 0, 0 | NA mm | — |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 17; n = 2, 0, 0, 1 | 4.5 mm | Standard Deviation 6.4 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 3 AM; n = 53, 53, 53, 49 | 4.1 mm | Standard Deviation 7 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 18; n = 0, 0, 1, 0 | NA mm | — |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 22; n = 0, 1, 1, 0 | NA mm | — |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 19; n = 1, 0, 0, 0 | 0.0 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 20; n = 0, 1, 0, 0 | NA mm | — |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 36; n = 1, 1, 1, 1 | 0.0 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 21; n = 1, 0, 0, 0 | 0.0 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 3 PM; n = 53, 55, 55, 50 | 4.7 mm | Standard Deviation 9.8 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 4 AM; n = 52, 53, 52, 48 | 2.8 mm | Standard Deviation 6 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 35; n = 1, 0, 1, 1 | 0.0 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 4 PM; n = 53, 52, 55, 52 | 4.5 mm | Standard Deviation 9.2 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 5 AM; n = 54, 54, 53, 50 | 3.6 mm | Standard Deviation 9.9 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 34; n = 1, 0, 0, 0 | 0.0 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 5 PM; n = 54, 55, 54, 51 | 3.9 mm | Standard Deviation 8.5 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 1 PM; n = 54, 54, 51, 51 | 6.6 mm | Standard Deviation 10.2 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 33;n = 0, 0, 2, 0 | NA mm | — |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 6 AM; n = 53, 54, 53, 50 | 3.5 mm | Standard Deviation 6.3 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 6 PM; n = 54, 53, 54, 50 | 2.9 mm | Standard Deviation 5.5 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 32; n = 0, 0, 5, 0 | NA mm | — |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 7; n = 54, 54, 54, 53 | 2.1 mm | Standard Deviation 5.3 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 43; n = 0, 1, 0, 0 | NA mm | — |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 8; n = 22, 28, 21, 13 | 1.3 mm | Standard Deviation 2.3 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 2 AM; n = 55, 55, 55, 54 | 7.7 mm | Standard Deviation 11.1 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 30; n = 15, 13, 6, 5 | 0.8 mm | Standard Deviation 2.8 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 9; n = 4, 4, 3, 2 | 0.0 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 29; n = 16, 14, 18, 13 | 0.1 mm | Standard Deviation 0.3 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 10; 1, 2, 3, 1 | 0.0 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 11; n = 1, 2, 4, 1 | 0.0 mm | Standard Deviation 0 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 37; n = 0, 1, 0, 0 | NA mm | — |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 28; n = 11, 12, 14, 25 | 0.6 mm | Standard Deviation 0.9 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 12; n = 2, 2, 2, 1 | 2.5 mm | Standard Deviation 3.5 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 13; n = 11, 8, 15, 9 | 1.1 mm | Standard Deviation 3.3 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 2 PM; n = 52, 55, 53, 53 | 5.3 mm | Standard Deviation 9.4 |
| Balanced Salt Solution (BSS) | Ocular Pain VAS Score After Day 0 | Day 14; n = 17, 16, 21, 26 | 2.7 mm | Standard Deviation 7.7 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 33;n = 0, 0, 2, 0 | NA mm | — |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 14; n = 17, 16, 21, 26 | 0.2 mm | Standard Deviation 0.5 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 5 PM; n = 54, 55, 54, 51 | 3.9 mm | Standard Deviation 10.4 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 15; 22, 25, 18, 14 | 1.8 mm | Standard Deviation 8 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 11; n = 1, 2, 4, 1 | 0.5 mm | Standard Deviation 0.7 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 26; n = 0, 1, 0, 0 | 0.0 mm | Standard Deviation 0 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 9; n = 4, 4, 3, 2 | 0.3 mm | Standard Deviation 0.5 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 16; 1, 7, 2, 5 | 0.0 mm | Standard Deviation 0 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 36; n = 1, 1, 1, 1 | 50.0 mm | Standard Deviation 0 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 29; n = 16, 14, 18, 13 | 0.1 mm | Standard Deviation 0.3 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 6 AM; n = 53, 54, 53, 50 | 4.6 mm | Standard Deviation 13.3 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 17; n = 2, 0, 0, 1 | NA mm | — |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 1 PM; n = 54, 54, 51, 51 | 12.6 mm | Standard Deviation 19.4 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 22; n = 0, 1, 1, 0 | 0.0 mm | Standard Deviation 0 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 32; n = 0, 0, 5, 0 | NA mm | — |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 18; n = 0, 0, 1, 0 | NA mm | — |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 3 AM; n = 53, 53, 53, 49 | 5.4 mm | Standard Deviation 11.5 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 2 AM; n = 55, 55, 55, 54 | 10.8 mm | Standard Deviation 18.2 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 6 PM; n = 54, 53, 54, 50 | 4.0 mm | Standard Deviation 11 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 19; n = 1, 0, 0, 0 | NA mm | — |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 2 PM; n = 52, 55, 53, 53 | 7.3 mm | Standard Deviation 15.5 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 21; n = 1, 0, 0, 0 | NA mm | — |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 37; n = 0, 1, 0, 0 | 0.0 mm | Standard Deviation 0 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 20; n = 0, 1, 0, 0 | 0.0 mm | Standard Deviation 0 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 27; n = 9, 9, 6, 5 | 0.1 mm | Standard Deviation 0.3 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 13; n = 11, 8, 15, 9 | 0.3 mm | Standard Deviation 0.5 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 7; n = 54, 54, 54, 53 | 3.5 mm | Standard Deviation 9 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 3 PM; n = 53, 55, 55, 50 | 5.1 mm | Standard Deviation 11 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 1 AM; n = 55, 54, 55, 55 | 13.0 mm | Standard Deviation 18.1 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 35; n = 1, 0, 1, 1 | NA mm | — |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 10; 1, 2, 3, 1 | 0.5 mm | Standard Deviation 0.7 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 4 AM; n = 52, 53, 52, 48 | 3.5 mm | Standard Deviation 8.3 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 31; n = 2, 2, 1, 3 | 0.0 mm | Standard Deviation 0 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 30; n = 15, 13, 6, 5 | 0.3 mm | Standard Deviation 0.9 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 12; n = 2, 2, 2, 1 | 0.5 mm | Standard Deviation 0.7 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 4 PM; n = 53, 52, 55, 52 | 3.7 mm | Standard Deviation 9.4 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 43; n = 0, 1, 0, 0 | 0.0 mm | Standard Deviation 0 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 34; n = 1, 0, 0, 0 | NA mm | — |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 8; n = 22, 28, 21, 13 | 4.9 mm | Standard Deviation 14.7 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 5 AM; n = 54, 54, 53, 50 | 6.4 mm | Standard Deviation 18.5 |
| OMS302 Mydriatic Solution (PE) | Ocular Pain VAS Score After Day 0 | Day 28; n = 11, 12, 14, 25 | 0.0 mm | Standard Deviation 0 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 5 AM; n = 54, 54, 53, 50 | 3.4 mm | Standard Deviation 10.6 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 12; n = 2, 2, 2, 1 | 0.0 mm | Standard Deviation 0 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 1 AM; n = 55, 54, 55, 55 | 2.7 mm | Standard Deviation 8.3 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 1 PM; n = 54, 54, 51, 51 | 6.8 mm | Standard Deviation 15.1 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 2 AM; n = 55, 55, 55, 54 | 9.5 mm | Standard Deviation 18.9 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 2 PM; n = 52, 55, 53, 53 | 7.2 mm | Standard Deviation 15.4 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 3 AM; n = 53, 53, 53, 49 | 4.8 mm | Standard Deviation 11.3 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 3 PM; n = 53, 55, 55, 50 | 3.7 mm | Standard Deviation 8.7 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 4 AM; n = 52, 53, 52, 48 | 3.9 mm | Standard Deviation 10.8 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 4 PM; n = 53, 52, 55, 52 | 4.8 mm | Standard Deviation 14.2 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 5 PM; n = 54, 55, 54, 51 | 3.3 mm | Standard Deviation 9.6 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 6 AM; n = 53, 54, 53, 50 | 3.6 mm | Standard Deviation 10.2 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 6 PM; n = 54, 53, 54, 50 | 2.7 mm | Standard Deviation 9.3 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 7; n = 54, 54, 54, 53 | 3.3 mm | Standard Deviation 11 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 8; n = 22, 28, 21, 13 | 0.6 mm | Standard Deviation 1 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 9; n = 4, 4, 3, 2 | 0.0 mm | Standard Deviation 0 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 10; 1, 2, 3, 1 | 0.0 mm | Standard Deviation 0 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 11; n = 1, 2, 4, 1 | 0.0 mm | Standard Deviation 0 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 13; n = 11, 8, 15, 9 | 0.7 mm | Standard Deviation 1.8 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 14; n = 17, 16, 21, 26 | 1.0 mm | Standard Deviation 2.2 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 15; 22, 25, 18, 14 | 0.2 mm | Standard Deviation 0.4 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 16; 1, 7, 2, 5 | 0.0 mm | Standard Deviation 0 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 17; n = 2, 0, 0, 1 | NA mm | — |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 18; n = 0, 0, 1, 0 | 0.0 mm | Standard Deviation 0 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 19; n = 1, 0, 0, 0 | NA mm | — |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 20; n = 0, 1, 0, 0 | NA mm | — |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 21; n = 1, 0, 0, 0 | NA mm | — |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 22; n = 0, 1, 1, 0 | 0.0 mm | Standard Deviation 0 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 26; n = 0, 1, 0, 0 | NA mm | — |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 27; n = 9, 9, 6, 5 | 0.0 mm | Standard Deviation 0 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 28; n = 11, 12, 14, 25 | 0.8 mm | Standard Deviation 2.2 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 29; n = 16, 14, 18, 13 | 1.6 mm | Standard Deviation 5.1 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 30; n = 15, 13, 6, 5 | 0.0 mm | Standard Deviation 0 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 31; n = 2, 2, 1, 3 | 0.0 mm | Standard Deviation 0 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 32; n = 0, 0, 5, 0 | 0.0 mm | Standard Deviation 0 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 33;n = 0, 0, 2, 0 | 0.0 mm | Standard Deviation 0 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 34; n = 1, 0, 0, 0 | NA mm | — |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 35; n = 1, 0, 1, 1 | 0.0 mm | Standard Deviation 0 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 36; n = 1, 1, 1, 1 | 0.0 mm | Standard Deviation 0 |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 37; n = 0, 1, 0, 0 | NA mm | — |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Pain VAS Score After Day 0 | Day 43; n = 0, 1, 0, 0 | NA mm | — |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 27; n = 9, 9, 6, 5 | 0.2 mm | Standard Deviation 0.4 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 11; n = 1, 2, 4, 1 | 0.0 mm | Standard Deviation 0 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 10; 1, 2, 3, 1 | 0.0 mm | Standard Deviation 0 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 3 AM; n = 53, 53, 53, 49 | 8.9 mm | Standard Deviation 18.8 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 28; n = 11, 12, 14, 25 | 0.2 mm | Standard Deviation 0.7 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 9; n = 4, 4, 3, 2 | 0.0 mm | Standard Deviation 0 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 12; n = 2, 2, 2, 1 | 0.0 mm | Standard Deviation 0 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 2 PM; n = 52, 55, 53, 53 | 6.4 mm | Standard Deviation 11.8 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 29; n = 16, 14, 18, 13 | 0.0 mm | Standard Deviation 0 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 8; n = 22, 28, 21, 13 | 2.2 mm | Standard Deviation 6.3 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 7; n = 54, 54, 54, 53 | 4.5 mm | Standard Deviation 13.9 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 1 AM; n = 55, 54, 55, 55 | 7.7 mm | Standard Deviation 18.4 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 36; n = 1, 1, 1, 1 | 0.0 mm | Standard Deviation 0 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 31; n = 2, 2, 1, 3 | 0.0 mm | Standard Deviation 0 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 6 PM; n = 54, 53, 54, 50 | 4.6 mm | Standard Deviation 12.2 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 6 AM; n = 53, 54, 53, 50 | 6.0 mm | Standard Deviation 14.3 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 2 AM; n = 55, 55, 55, 54 | 10.9 mm | Standard Deviation 13.7 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 32; n = 0, 0, 5, 0 | NA mm | — |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 5 PM; n = 54, 55, 54, 51 | 5.2 mm | Standard Deviation 12.5 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 5 AM; n = 54, 54, 53, 50 | 6.5 mm | Standard Deviation 14.8 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 43; n = 0, 1, 0, 0 | NA mm | — |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 33;n = 0, 0, 2, 0 | NA mm | — |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 30; n = 15, 13, 6, 5 | 0.8 mm | Standard Deviation 1.8 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 4 PM; n = 53, 52, 55, 52 | 4.1 mm | Standard Deviation 8.3 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 37; n = 0, 1, 0, 0 | NA mm | — |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 34; n = 1, 0, 0, 0 | NA mm | — |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 20; n = 0, 1, 0, 0 | NA mm | — |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 19; n = 1, 0, 0, 0 | NA mm | — |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 4 AM; n = 52, 53, 52, 48 | 5.0 mm | Standard Deviation 10.5 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 21; n = 1, 0, 0, 0 | NA mm | — |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 18; n = 0, 0, 1, 0 | NA mm | — |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 17; n = 2, 0, 0, 1 | 0.0 mm | Standard Deviation 0 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 3 PM; n = 53, 55, 55, 50 | 4.4 mm | Standard Deviation 10.7 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 22; n = 0, 1, 1, 0 | NA mm | — |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 16; 1, 7, 2, 5 | 0.0 mm | Standard Deviation 0 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 15; 22, 25, 18, 14 | 4.5 mm | Standard Deviation 13.4 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 1 PM; n = 54, 54, 51, 51 | 11.6 mm | Standard Deviation 20.6 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 26; n = 0, 1, 0, 0 | NA mm | — |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 14; n = 17, 16, 21, 26 | 0.6 mm | Standard Deviation 1.4 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 13; n = 11, 8, 15, 9 | 0.0 mm | Standard Deviation 0 |
| OMS302 Solution | Ocular Pain VAS Score After Day 0 | Day 35; n = 1, 0, 1, 1 | 0.0 mm | Standard Deviation 0 |
Secondary
Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: 14 days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery | None | 52 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery | Mild | 3 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery | Moderate | 0 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery | Mild | 4 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery | Moderate | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery | None | 51 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery | Moderate | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery | Mild | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery | None | 53 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery | Mild | 4 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery | None | 49 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery | Moderate | 0 participants |
p-value: 0.646Cochran-Mantel-Haenszel
p-value: 0.95Cochran-Mantel-Haenszel
p-value: 0.16Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Two hours
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery | Severe | 0 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery | None | 55 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery | Mild | 1 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery | Moderate | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery | Moderate | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery | Mild | 6 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery | None | 50 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery | None | 52 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery | Mild | 2 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery | Moderate | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery | Severe | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery | Mild | 4 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery | None | 48 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery | Moderate | 2 participants |
p-value: 0.124Cochran-Mantel-Haenszel
p-value: 0.298Cochran-Mantel-Haenszel
p-value: 0.291Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Up to 30 days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination | None | 52 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination | Mild | 3 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination | Moderate | 0 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination | Mild | 2 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination | Moderate | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination | None | 52 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination | Moderate | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination | Mild | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination | None | 53 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination | Mild | 3 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination | None | 50 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination | Moderate | 0 participants |
p-value: 1Cochran-Mantel-Haenszel
p-value: 0.667Cochran-Mantel-Haenszel
p-value: 0.303Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: One day
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery | None | 48 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery | Mild | 7 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery | Moderate | 0 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery | Severe | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery | Mild | 9 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery | Moderate | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery | None | 45 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery | Moderate | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery | Mild | 6 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery | None | 48 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery | Mild | 4 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery | None | 50 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery | Moderate | 0 participants |
p-value: 0.401Cochran-Mantel-Haenszel
p-value: 0.2Chi-squared, Corrected
p-value: 0.478Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Seven days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery | None | 49 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery | Mild | 4 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery | Moderate | 0 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery | Mild | 4 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery | Moderate | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery | None | 52 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery | Moderate | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery | Mild | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery | None | 52 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery | Mild | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery | None | 52 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery | Moderate | 2 participants |
p-value: 0.148Cochran-Mantel-Haenszel
p-value: 0.156Cochran-Mantel-Haenszel
p-value: 0.381Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Six hours
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery | None | 44 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery | Mild | 7 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery | Moderate | 3 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery | Mild | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery | Moderate | 3 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery | None | 49 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery | None | 41 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery | Mild | 8 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery | Moderate | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery | Moderate | 2 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery | Mild | 5 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery | None | 43 participants |
p-value: 0.825Cochran-Mantel-Haenszel
p-value: 0.211Cochran-Mantel-Haenszel
p-value: 0.589Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Two days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery | None | 52 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery | Mild | 3 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery | Severe | 0 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery | Moderate | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery | None | 48 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery | Mild | 7 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery | Moderate | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery | None | 46 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery | Severe | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery | Moderate | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery | Mild | 8 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery | None | 49 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery | Moderate | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery | Mild | 5 participants |
p-value: 0.758Cochran-Mantel-Haenszel
p-value: 0.521Cochran-Mantel-Haenszel
p-value: 0.432Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: 14 days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery | None | 31 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery | Mild | 23 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery | Moderate | 1 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery | Mild | 16 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery | Moderate | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery | None | 38 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery | Moderate | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery | Mild | 16 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery | Severe | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery | None | 36 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery | Mild | 9 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery | None | 42 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery | Moderate | 2 participants |
p-value: 0.018Cochran-Mantel-Haenszel
p-value: 0.292Cochran-Mantel-Haenszel
p-value: 0.298Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Up to 30 days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination | Moderate | 2 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination | Mild | 12 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination | None | 41 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination | Mild | 10 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination | None | 44 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination | Moderate | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination | None | 40 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination | Moderate | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination | Mild | 14 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination | Mild | 6 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination | Moderate | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination | None | 46 participants |
p-value: 0.271Cochran-Mantel-Haenszel
p-value: 0.345Cochran-Mantel-Haenszel
p-value: 0.096Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: One day
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery | None | 36 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery | Mild | 13 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery | Moderate | 7 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery | Mild | 25 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery | Moderate | 5 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery | None | 25 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery | Moderate | 2 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery | Mild | 16 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery | None | 37 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery | Severe | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery | Mild | 16 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery | None | 35 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery | Moderate | 2 participants |
p-value: 0.244Cochran-Mantel-Haenszel
p-value: 0.122Cochran-Mantel-Haenszel
p-value: 0.79Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Seven days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days | None | 27 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days | Mild | 23 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days | Moderate | 3 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days | Severe | 2 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days | Moderate | 5 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days | Mild | 17 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days | None | 32 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days | Moderate | 2 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days | Mild | 17 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days | None | 34 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days | Mild | 15 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days | None | 37 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days | Severe | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days | Moderate | 2 participants |
p-value: 0.228Cochran-Mantel-Haenszel
p-value: 0.564Cochran-Mantel-Haenszel
p-value: 0.755Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Six hours
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery | None | 26 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery | Mild | 19 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery | Moderate | 8 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery | Severe | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery | Mild | 16 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery | Moderate | 4 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery | Severe | 2 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery | None | 31 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery | Moderate | 2 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery | Mild | 16 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery | None | 31 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery | Severe | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery | Mild | 10 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery | None | 34 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery | Moderate | 5 participants |
p-value: 0.226Cochran-Mantel-Haenszel
p-value: 0.602Cochran-Mantel-Haenszel
p-value: 0.29Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Two days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery | None | 37 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery | Mild | 16 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery | Moderate | 3 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery | Mild | 11 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery | Moderate | 3 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery | Severe | 2 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery | None | 39 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery | Moderate | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery | Mild | 15 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery | Severe | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery | None | 38 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery | Mild | 15 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery | None | 35 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery | Moderate | 5 participants |
p-value: 0.752Cochran-Mantel-Haenszel
p-value: 0.355Cochran-Mantel-Haenszel
p-value: 0.292Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Two hours
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery | None | 32 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery | Mild | 17 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery | Moderate | 6 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery | Severe | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery | Mild | 24 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery | Moderate | 4 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery | Severe | 2 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery | None | 26 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery | Moderate | 3 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery | Mild | 20 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery | Severe | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery | None | 31 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery | Severe | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery | Mild | 19 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery | None | 25 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery | Moderate | 9 participants |
p-value: 0.681Cochran-Mantel-Haenszel
p-value: 0.429Cochran-Mantel-Haenszel
p-value: 0.306Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: 14 days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery | Moderate | 6 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery | Severe | 0 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery | Mild | 10 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery | None | 39 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery | Mild | 16 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery | Moderate | 5 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery | None | 34 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery | Mild | 13 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery | None | 39 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery | Severe | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery | Moderate | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery | Moderate | 2 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery | None | 47 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery | Mild | 4 participants |
p-value: 0.075Cochran-Mantel-Haenszel
p-value: 0.005Cochran-Mantel-Haenszel
p-value: 0.078Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Up to 30 days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination | None | 38 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination | Mild | 14 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination | Moderate | 3 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination | Mild | 6 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination | Moderate | 6 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination | None | 42 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination | Moderate | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination | Mild | 10 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination | None | 44 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination | Mild | 7 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination | None | 44 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination | Moderate | 2 participants |
p-value: 0.226Cochran-Mantel-Haenszel
p-value: 0.357Cochran-Mantel-Haenszel
p-value: 0.291Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: One day
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery | None | 34 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery | Mild | 15 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery | Moderate | 7 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery | Mild | 19 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery | Moderate | 4 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery | Severe | 3 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery | None | 29 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery | Moderate | 2 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery | Mild | 17 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery | None | 36 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery | Severe | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery | Mild | 12 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery | None | 38 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery | Moderate | 3 participants |
p-value: 0.374Cochran-Mantel-Haenszel
p-value: 0.265Cochran-Mantel-Haenszel
p-value: 0.555Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Seven days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery | Mild | 16 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery | Severe | 0 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery | None | 36 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery | Moderate | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery | None | 33 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery | Mild | 17 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery | Moderate | 6 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery | None | 34 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery | Moderate | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery | Mild | 18 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery | Severe | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery | Mild | 11 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery | Moderate | 2 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery | None | 41 participants |
p-value: 0.476Cochran-Mantel-Haenszel
p-value: 0.169Cochran-Mantel-Haenszel
p-value: 0.31Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Six hours
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery | None | 24 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery | Mild | 21 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery | Moderate | 7 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery | Severe | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery | Mild | 20 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery | Moderate | 10 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery | Severe | 3 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery | None | 20 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery | Moderate | 10 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery | Mild | 13 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery | None | 26 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery | Mild | 19 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery | None | 23 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery | Moderate | 8 participants |
p-value: 0.778Cochran-Mantel-Haenszel
p-value: 0.348Cochran-Mantel-Haenszel
p-value: 0.477Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Two days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery | None | 36 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery | Mild | 19 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery | Moderate | 1 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery | Mild | 17 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery | Moderate | 5 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery | Severe | 2 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery | None | 31 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery | Moderate | 3 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery | Mild | 13 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery | None | 39 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery | Mild | 8 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery | None | 43 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery | Moderate | 4 participants |
p-value: 0.031Cochran-Mantel-Haenszel
p-value: 0.059Cochran-Mantel-Haenszel
p-value: 0.472Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Two hours
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery | None | 27 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery | Mild | 21 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery | Moderate | 6 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery | Severe | 2 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery | Mild | 17 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery | Moderate | 12 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery | Severe | 3 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery | None | 24 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery | Moderate | 8 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery | Mild | 18 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery | Severe | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery | None | 28 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery | Severe | 2 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery | Mild | 25 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery | None | 17 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery | Moderate | 10 participants |
p-value: 0.32Cochran-Mantel-Haenszel
p-value: 0.39Cochran-Mantel-Haenszel
p-value: 0.23Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: 14 days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery | Moderate | 1 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery | Severe | 0 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery | Mild | 6 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery | None | 48 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery | Mild | 10 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery | Moderate | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery | None | 45 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery | Moderate | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery | None | 44 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery | Mild | 10 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery | None | 44 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery | Moderate | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery | Mild | 8 participants |
p-value: 0.811Cochran-Mantel-Haenszel
p-value: 0.552Cochran-Mantel-Haenszel
p-value: 0.549Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Up to 30 days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination | None | 43 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination | Mild | 11 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination | Moderate | 1 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination | Mild | 8 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination | Moderate | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination | None | 46 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination | Moderate | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination | Mild | 7 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination | None | 47 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination | Mild | 5 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination | None | 48 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination | Moderate | 0 participants |
p-value: 0.173Cochran-Mantel-Haenszel
p-value: 0.362Cochran-Mantel-Haenszel
p-value: 0.559Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Six hours
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery | None | 44 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery | Mild | 7 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery | Moderate | 3 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery | Mild | 9 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery | Moderate | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery | None | 43 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery | Moderate | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery | Mild | 10 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery | None | 39 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery | Mild | 6 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery | None | 43 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery | Moderate | 1 participants |
p-value: 0.632Cochran-Mantel-Haenszel
p-value: 0.778Cochran-Mantel-Haenszel
p-value: 0.336Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: One day
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery | None | 45 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery | Mild | 10 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery | Moderate | 1 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery | Mild | 6 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery | Moderate | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery | None | 49 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery | Moderate | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery | Mild | 6 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery | None | 49 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery | Mild | 6 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery | None | 46 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery | Moderate | 2 participants |
p-value: 0.528Cochran-Mantel-Haenszel
p-value: 0.362Cochran-Mantel-Haenszel
p-value: 0.353Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Seven days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery | Moderate | 1 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery | Mild | 13 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery | None | 39 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery | Mild | 9 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery | None | 47 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery | Moderate | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery | None | 40 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery | Moderate | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery | Mild | 13 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery | Mild | 12 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery | None | 42 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery | Moderate | 1 participants |
p-value: 0.945Cochran-Mantel-Haenszel
p-value: 0.438Cochran-Mantel-Haenszel
p-value: 0.596Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Two days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery | None | 45 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery | Moderate | 0 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery | Mild | 11 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery | Mild | 10 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery | None | 44 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery | Moderate | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery | Mild | 9 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery | Moderate | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery | None | 46 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery | Mild | 14 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery | None | 41 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery | Moderate | 0 participants |
p-value: 0.463Cochran-Mantel-Haenszel
p-value: 0.406Cochran-Mantel-Haenszel
p-value: 0.245Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Two hours
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery | Mild | 5 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery | None | 49 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery | Moderate | 1 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery | Severe | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery | Mild | 7 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery | Moderate | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery | None | 48 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery | None | 45 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery | Mild | 9 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery | Moderate | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery | Severe | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery | Moderate | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery | Mild | 6 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery | None | 47 participants |
p-value: 0.789Cochran-Mantel-Haenszel
p-value: 0.977Cochran-Mantel-Haenszel
p-value: 0.336Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: 14 days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery | None | 43 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery | Mild | 10 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery | Moderate | 2 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery | Mild | 18 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery | Moderate | 2 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery | None | 35 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery | Moderate | 3 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery | Mild | 9 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery | None | 42 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery | Severe | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery | Mild | 12 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery | None | 39 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery | Moderate | 1 participants |
p-value: 0.642Cochran-Mantel-Haenszel
p-value: 0.442Cochran-Mantel-Haenszel
p-value: 0.467Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Up to 30 days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination | None | 44 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination | Mild | 10 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination | Moderate | 1 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination | Mild | 17 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination | Moderate | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination | None | 36 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination | Moderate | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination | Mild | 12 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination | None | 42 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination | Severe | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination | Mild | 10 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination | None | 40 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination | Moderate | 2 participants |
p-value: 0.695Cochran-Mantel-Haenszel
p-value: 0.355Cochran-Mantel-Haenszel
p-value: 0.369Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: One day
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery | None | 20 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery | Mild | 19 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery | Moderate | 13 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery | Severe | 4 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery | Mild | 22 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery | Moderate | 11 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery | Severe | 6 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery | None | 16 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery | Moderate | 2 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery | Mild | 16 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery | Severe | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery | None | 36 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery | Severe | 2 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery | Mild | 20 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery | None | 23 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery | Moderate | 9 participants |
p-value: 0.663Cochran-Mantel-Haenszel
p-value: 0.326Cochran-Mantel-Haenszel
p-value: 0.045Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Seven days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery | None | 30 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery | Mild | 18 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery | Moderate | 4 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery | Severe | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery | Mild | 16 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery | Moderate | 8 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery | Severe | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery | None | 31 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery | Moderate | 3 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery | Mild | 11 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery | Severe | 2 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery | None | 37 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery | Severe | 5 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery | Mild | 12 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery | None | 37 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery | Moderate | 1 participants |
p-value: 0.1Cochran-Mantel-Haenszel
p-value: 0.029Cochran-Mantel-Haenszel
p-value: 0.525Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Six hours
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery | None | 26 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery | Mild | 17 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery | Moderate | 7 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery | Severe | 3 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery | Mild | 16 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery | Moderate | 7 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery | Severe | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery | None | 29 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery | Moderate | 4 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery | Mild | 12 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery | None | 33 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery | Severe | 2 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery | Mild | 18 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery | None | 29 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery | Moderate | 1 participants |
p-value: 0.186Cochran-Mantel-Haenszel
p-value: 0.191Cochran-Mantel-Haenszel
p-value: 0.167Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Two days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery | None | 26 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery | Mild | 18 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery | Moderate | 12 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery | Mild | 24 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery | Moderate | 4 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery | Severe | 4 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery | None | 23 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery | Moderate | 5 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery | Mild | 13 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery | Severe | 3 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery | None | 34 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery | Severe | 4 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery | Mild | 23 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery | None | 19 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery | Moderate | 9 participants |
p-value: 0.106Cochran-Mantel-Haenszel
p-value: 0.519Cochran-Mantel-Haenszel
p-value: 0.039Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Two hours
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery | None | 37 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery | Mild | 13 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery | Moderate | 4 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery | Severe | 2 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery | Mild | 22 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery | Moderate | 3 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery | Severe | 4 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery | None | 27 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery | Moderate | 6 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery | Mild | 13 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery | None | 36 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery | Severe | 2 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery | Mild | 16 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery | None | 32 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery | Moderate | 4 participants |
p-value: 0.893Cochran-Mantel-Haenszel
p-value: 0.553Cochran-Mantel-Haenszel
p-value: 0.412Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: 14 days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery | None | 44 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery | Moderate | 4 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery | Mild | 7 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery | None | 45 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery | Moderate | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery | Mild | 10 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery | Mild | 3 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery | None | 51 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery | Moderate | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery | None | 42 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery | Moderate | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery | Mild | 11 participants |
p-value: 0.085Cochran-Mantel-Haenszel
p-value: 0.742Cochran-Mantel-Haenszel
p-value: 0.021Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: up to 30 days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination | None | 43 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination | Moderate | 1 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination | Mild | 11 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination | None | 44 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination | Moderate | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination | Mild | 9 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination | Mild | 3 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination | None | 51 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination | Moderate | 0 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination | None | 49 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination | Moderate | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination | Mild | 3 participants |
p-value: 0.081Cochran-Mantel-Haenszel
p-value: 0.202Cochran-Mantel-Haenszel
p-value: 0.606Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: One day
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery | None | 34 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery | Mild | 15 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery | Moderate | 5 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery | Severe | 2 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery | Mild | 19 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery | Moderate | 4 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery | Severe | 3 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery | None | 29 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery | Moderate | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery | Mild | 6 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery | None | 48 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery | Severe | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery | Mild | 10 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery | None | 42 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery | Moderate | 1 participants |
p-value: 0.177Cochran-Mantel-Haenszel
p-value: 0.051Cochran-Mantel-Haenszel
p-value: 0.497Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Seven days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery | None | 39 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery | Mild | 13 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery | Moderate | 1 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery | Mild | 21 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery | Moderate | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery | Severe | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery | None | 33 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery | Moderate | 2 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery | Mild | 5 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery | None | 46 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery | Severe | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery | Mild | 13 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery | None | 40 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery | Moderate | 1 participants |
p-value: 0.812Cochran-Mantel-Haenszel
p-value: 0.48Cochran-Mantel-Haenszel
p-value: 0.16Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Six hours
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery | None | 34 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery | Mild | 12 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery | Moderate | 7 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery | Severe | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery | Mild | 15 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery | Moderate | 6 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery | Severe | 3 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery | None | 29 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery | Moderate | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery | Mild | 6 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery | Severe | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery | None | 43 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery | Severe | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery | Mild | 13 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery | None | 35 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery | Moderate | 1 participants |
p-value: 0.229Cochran-Mantel-Haenszel
p-value: 0.162Cochran-Mantel-Haenszel
p-value: 0.226Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Two days
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery | None | 37 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery | Mild | 18 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery | Moderate | 1 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery | Mild | 18 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery | Moderate | 6 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery | Severe | 1 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery | None | 30 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery | Moderate | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery | Mild | 7 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery | Severe | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery | None | 47 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery | Severe | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery | Mild | 12 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery | None | 41 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery | Moderate | 1 participants |
p-value: 0.48Cochran-Mantel-Haenszel
p-value: 0.09Cochran-Mantel-Haenszel
p-value: 0.439Cochran-Mantel-Haenszel
Secondary
Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: Two hours
Population: Subjects with scores at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery | None | 41 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery | Mild | 12 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery | Moderate | 3 participants |
| Balanced Salt Solution (BSS) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery | Severe | 0 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery | Mild | 13 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery | Moderate | 7 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery | Severe | 2 participants |
| OMS302 Mydriatic Solution (PE) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery | None | 34 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery | Moderate | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery | Mild | 6 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery | Severe | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery | None | 48 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery | Severe | 1 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery | Mild | 14 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery | None | 35 participants |
| OMS302 Solution | Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery | Moderate | 4 participants |
p-value: 0.63Cochran-Mantel-Haenszel
p-value: 0.769Cochran-Mantel-Haenszel
p-value: 0.025Cochran-Mantel-Haenszel
Secondary
Postoperative Mean Anterior Chamber Cell Count, Day 1
The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as \> 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.
Time frame: One day
Population: Subjects with data at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Postoperative Mean Anterior Chamber Cell Count, Day 1 | 11.2 cells | Standard Deviation 9.5 |
| OMS302 Mydriatic Solution (PE) | Postoperative Mean Anterior Chamber Cell Count, Day 1 | 9.3 cells | Standard Deviation 9.7 |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Mean Anterior Chamber Cell Count, Day 1 | 10.4 cells | Standard Deviation 8.9 |
| OMS302 Solution | Postoperative Mean Anterior Chamber Cell Count, Day 1 | 8.4 cells | Standard Deviation 6.7 |
p-value: 0.134Wilcoxon rank-sum test
p-value: 0.71Wilcoxon rank-sum test
p-value: 0.31Wilcoxon rank-sum test
Secondary
Postoperative Mean Anterior Chamber Cell Count, Day 14
The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as \> 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.
Time frame: 14 days
Population: Subjects with data at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Postoperative Mean Anterior Chamber Cell Count, Day 14 | 1.6 cells | Standard Deviation 2.1 |
| OMS302 Mydriatic Solution (PE) | Postoperative Mean Anterior Chamber Cell Count, Day 14 | 1.3 cells | Standard Deviation 2.4 |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Mean Anterior Chamber Cell Count, Day 14 | 1.6 cells | Standard Deviation 2.7 |
| OMS302 Solution | Postoperative Mean Anterior Chamber Cell Count, Day 14 | 2.1 cells | Standard Deviation 3.9 |
p-value: 0.822Wilcoxon rank-sum test
p-value: 0.424Wilcoxon rank-sum test
p-value: 0.695Wilcoxon rank-sum test
Secondary
Postoperative Mean Anterior Chamber Cell Count, Day 2
The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as \> 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.
Time frame: Two days
Population: Subjects with data at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Postoperative Mean Anterior Chamber Cell Count, Day 2 | 9.1 cells | Standard Deviation 6.4 |
| OMS302 Mydriatic Solution (PE) | Postoperative Mean Anterior Chamber Cell Count, Day 2 | 6.8 cells | Standard Deviation 7.8 |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Mean Anterior Chamber Cell Count, Day 2 | 10.2 cells | Standard Deviation 7.6 |
| OMS302 Solution | Postoperative Mean Anterior Chamber Cell Count, Day 2 | 7.2 cells | Standard Deviation 6 |
p-value: 0.086Wilcoxon rank-sum test
p-value: 0.183Wilcoxon rank-sum test
p-value: 0.029Wilcoxon rank-sum test
Secondary
Postoperative Mean Anterior Chamber Cell Count, Day 30
The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as \> 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.
Time frame: 30 days
Population: Subjects with data at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Postoperative Mean Anterior Chamber Cell Count, Day 30 | 1.1 cells | Standard Deviation 2.3 |
| OMS302 Mydriatic Solution (PE) | Postoperative Mean Anterior Chamber Cell Count, Day 30 | 0.3 cells | Standard Deviation 0.8 |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Mean Anterior Chamber Cell Count, Day 30 | 0.5 cells | Standard Deviation 1.2 |
| OMS302 Solution | Postoperative Mean Anterior Chamber Cell Count, Day 30 | 0.5 cells | Standard Deviation 1.2 |
p-value: 0.489Wilcoxon rank-sum test
p-value: 0.459Wilcoxon rank-sum test
p-value: 0.99Wilcoxon rank-sum test
Secondary
Postoperative Mean Anterior Chamber Cell Count, Day 7
The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as \> 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.
Time frame: Seven days
Population: Subjects with data at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Postoperative Mean Anterior Chamber Cell Count, Day 7 | 4.5 cells | Standard Deviation 5.2 |
| OMS302 Mydriatic Solution (PE) | Postoperative Mean Anterior Chamber Cell Count, Day 7 | 4.2 cells | Standard Deviation 7.5 |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Mean Anterior Chamber Cell Count, Day 7 | 3.6 cells | Standard Deviation 4.6 |
| OMS302 Solution | Postoperative Mean Anterior Chamber Cell Count, Day 7 | 6.9 cells | Standard Deviation 10.1 |
p-value: 0.206Wilcoxon rank-sum test
p-value: 0.021Wilcoxon rank-sum test
p-value: 0.026Wilcoxon rank-sum test
Secondary
Postoperative Mean Anterior Chamber Cell Count, Two Hours Post-Surgery
The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as \> 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.
Time frame: Two hours
Population: Subjects with data at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Postoperative Mean Anterior Chamber Cell Count, Two Hours Post-Surgery | 11.2 cells | Standard Deviation 9.4 |
| OMS302 Mydriatic Solution (PE) | Postoperative Mean Anterior Chamber Cell Count, Two Hours Post-Surgery | 9.2 cells | Standard Deviation 11.1 |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Mean Anterior Chamber Cell Count, Two Hours Post-Surgery | 10.9 cells | Standard Deviation 10.1 |
| OMS302 Solution | Postoperative Mean Anterior Chamber Cell Count, Two Hours Post-Surgery | 10.3 cells | Standard Deviation 8.6 |
p-value: 0.695Wilcoxon rank-sum test
p-value: 0.166Wilcoxon rank-sum test
p-value: 0.987Wilcoxon rank-sum test
Secondary
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, 2 Hours Post Surgery
TPostoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time frame: Two hours
Population: Subjects with scores at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, 2 Hours Post Surgery | 2.7 units on a scale | Standard Deviation 1.4 |
| OMS302 Mydriatic Solution (PE) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, 2 Hours Post Surgery | 2.2 units on a scale | Standard Deviation 1.3 |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, 2 Hours Post Surgery | 2.5 units on a scale | Standard Deviation 1.3 |
| OMS302 Solution | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, 2 Hours Post Surgery | 2.5 units on a scale | Standard Deviation 1.2 |
p-value: 0.4222ANOVA
p-value: 0.2712ANOVA
p-value: 0.8819ANOVA
Secondary
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Baseline
Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time frame: Baseline
Population: Subjects with scores at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Baseline | 0.0 units on a scale | Standard Deviation 0 |
| OMS302 Mydriatic Solution (PE) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Baseline | 0.0 units on a scale | Standard Deviation 0 |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Baseline | 0.0 units on a scale | Standard Deviation 0.1 |
| OMS302 Solution | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Baseline | 0.0 units on a scale | Standard Deviation 0.1 |
p-value: 0.2066ANOVA
p-value: 0.2066ANOVA
p-value: 0.5263ANOVA
Secondary
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 1
Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time frame: One day
Population: Subjects with scores at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 1 | 2.7 units on a scale | Standard Deviation 1.4 |
| OMS302 Mydriatic Solution (PE) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 1 | 2.3 units on a scale | Standard Deviation 1.3 |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 1 | 2.6 units on a scale | Standard Deviation 1.3 |
| OMS302 Solution | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 1 | 2.2 units on a scale | Standard Deviation 1.1 |
p-value: 0.051ANOVA
p-value: 0.8084ANOVA
p-value: 0.1495ANOVA
Secondary
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 14
Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time frame: 14 days
Population: Subjects with scores at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 14 | 0.7 units on a scale | Standard Deviation 0.7 |
| OMS302 Mydriatic Solution (PE) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 14 | 0.6 units on a scale | Standard Deviation 0.8 |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 14 | 0.7 units on a scale | Standard Deviation 0.9 |
| OMS302 Solution | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 14 | 0.8 units on a scale | Standard Deviation 0.9 |
p-value: 0.5369ANOVA
p-value: 0.3763ANOVA
p-value: 0.6144ANOVA
Secondary
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 2
Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time frame: Two days
Population: Subjects with scores at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 2 | 2.4 units on a scale | Standard Deviation 1.3 |
| OMS302 Mydriatic Solution (PE) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 2 | 2.0 units on a scale | Standard Deviation 1.2 |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 2 | 2.6 units on a scale | Standard Deviation 1.4 |
| OMS302 Solution | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 2 | 2.2 units on a scale | Standard Deviation 1.2 |
p-value: 0.4099ANOVA
p-value: 0.6499ANOVA
p-value: 0.0765ANOVA
Secondary
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 30
Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time frame: 30 days
Population: Subjects with scores at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 30 | 0.4 units on a scale | Standard Deviation 0.7 |
| OMS302 Mydriatic Solution (PE) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 30 | 0.2 units on a scale | Standard Deviation 0.5 |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 30 | 0.3 units on a scale | Standard Deviation 0.6 |
| OMS302 Solution | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 30 | 0.2 units on a scale | Standard Deviation 0.4 |
p-value: 0.1374ANOVA
p-value: 0.9146ANOVA
p-value: 0.7599ANOVA
Secondary
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 7
Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time frame: Seven days
Population: Subjects with scores at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 7 | 1.5 units on a scale | Standard Deviation 1.2 |
| OMS302 Mydriatic Solution (PE) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 7 | 1.4 units on a scale | Standard Deviation 1.2 |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 7 | 1.5 units on a scale | Standard Deviation 1.3 |
| OMS302 Solution | Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 7 | 1.9 units on a scale | Standard Deviation 1.3 |
p-value: 0.0688ANOVA
p-value: 0.0314ANOVA
p-value: 0.0775ANOVA
Secondary
Postoperative Use of Ophthalmic Anti-inflammatory Medications
Ophthalmic anti-inflammatory medications were identified by reviewing concomitant medications. Subject incidence of ophthalmic anti-inflammatory medication use by post-surgery day was presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: up to 30 days
Population: All randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Bromfenac sodium | 2 participants |
| Balanced Salt Solution (BSS) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Dexamethasone | 1 participants |
| Balanced Salt Solution (BSS) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Difluprednate | 6 participants |
| Balanced Salt Solution (BSS) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Ketorlac | 0 participants |
| Balanced Salt Solution (BSS) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Ketorolac tromethamine | 0 participants |
| Balanced Salt Solution (BSS) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Loteprednol etabonate | 0 participants |
| Balanced Salt Solution (BSS) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Nepafenac | 10 participants |
| Balanced Salt Solution (BSS) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Prednisolone acetate | 25 participants |
| OMS302 Mydriatic Solution (PE) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Loteprednol etabonate | 1 participants |
| OMS302 Mydriatic Solution (PE) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Ketorolac tromethamine | 1 participants |
| OMS302 Mydriatic Solution (PE) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Dexamethasone | 0 participants |
| OMS302 Mydriatic Solution (PE) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Prednisolone acetate | 29 participants |
| OMS302 Mydriatic Solution (PE) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Nepafenac | 4 participants |
| OMS302 Mydriatic Solution (PE) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Ketorlac | 0 participants |
| OMS302 Mydriatic Solution (PE) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Difluprednate | 8 participants |
| OMS302 Mydriatic Solution (PE) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Bromfenac sodium | 9 participants |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Nepafenac | 7 participants |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Difluprednate | 7 participants |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Ketorlac | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Ketorolac tromethamine | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Loteprednol etabonate | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Prednisolone acetate | 28 participants |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Bromfenac sodium | 8 participants |
| OMS302 Anti-inflammatory Solution (KE) | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Dexamethasone | 0 participants |
| OMS302 Solution | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Difluprednate | 7 participants |
| OMS302 Solution | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Ketorlac | 0 participants |
| OMS302 Solution | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Dexamethasone | 2 participants |
| OMS302 Solution | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Bromfenac sodium | 6 participants |
| OMS302 Solution | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Ketorolac tromethamine | 0 participants |
| OMS302 Solution | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Prednisolone acetate | 29 participants |
| OMS302 Solution | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Nepafenac | 4 participants |
| OMS302 Solution | Postoperative Use of Ophthalmic Anti-inflammatory Medications | Loteprednol etabonate | 0 participants |
p-value: 0.4575Cochran-Mantel-Haenszel
p-value: 0.8318Cochran-Mantel-Haenszel
p-value: 0.8946Cochran-Mantel-Haenszel
Secondary
Subjects With Postoperative Ocular Inflammation SOIS = 0, Baseline
Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time frame: Baseline
Population: Subjects with scores at time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balanced Salt Solution (BSS) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Baseline | 56 participants |
| OMS302 Mydriatic Solution (PE) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Baseline | 56 participants |
| OMS302 Anti-inflammatory Solution (KE) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Baseline | 54 participants |
| OMS302 Solution | Subjects With Postoperative Ocular Inflammation SOIS = 0, Baseline | 54 participants |
p-value: 0.317Cochran-Mantel-Haenszel
p-value: 0.317Cochran-Mantel-Haenszel
p-value: 1Cochran-Mantel-Haenszel
Secondary
Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 1
Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time frame: One day
Population: Subjects with scores at time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balanced Salt Solution (BSS) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 1 | 1 participants |
| OMS302 Mydriatic Solution (PE) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 1 | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 1 | 1 participants |
| OMS302 Solution | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 1 | 0 participants |
p-value: 0.317Cochran-Mantel-Haenszel
p-value: 0.335Cochran-Mantel-Haenszel
p-value: 0.317Cochran-Mantel-Haenszel
Secondary
Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 14
Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time frame: 14 days
Population: Subjects with scores at time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balanced Salt Solution (BSS) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 14 | 25 participants |
| OMS302 Mydriatic Solution (PE) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 14 | 29 participants |
| OMS302 Anti-inflammatory Solution (KE) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 14 | 28 participants |
| OMS302 Solution | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 14 | 25 participants |
p-value: 0.842Cochran-Mantel-Haenszel
p-value: 0.619Cochran-Mantel-Haenszel
p-value: 0.711Cochran-Mantel-Haenszel
Secondary
Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 2
Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time frame: Two days
Population: Subjects with scores at time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balanced Salt Solution (BSS) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 2 | 1 participants |
| OMS302 Mydriatic Solution (PE) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 2 | 2 participants |
| OMS302 Anti-inflammatory Solution (KE) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 2 | 1 participants |
| OMS302 Solution | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 2 | 1 participants |
p-value: 1Cochran-Mantel-Haenszel
p-value: 0.559Cochran-Mantel-Haenszel
p-value: 1Cochran-Mantel-Haenszel
Secondary
Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 30
Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time frame: 30 days
Population: Subjects with scores at time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balanced Salt Solution (BSS) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 30 | 40 participants |
| OMS302 Mydriatic Solution (PE) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 30 | 43 participants |
| OMS302 Anti-inflammatory Solution (KE) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 30 | 42 participants |
| OMS302 Solution | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 30 | 40 participants |
p-value: 0.773Cochran-Mantel-Haenszel
p-value: 0.592Cochran-Mantel-Haenszel
p-value: 0.787Cochran-Mantel-Haenszel
Secondary
Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 7
Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time frame: Seven days
Population: Subjects with scores at time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balanced Salt Solution (BSS) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 7 | 9 participants |
| OMS302 Mydriatic Solution (PE) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 7 | 11 participants |
| OMS302 Anti-inflammatory Solution (KE) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 7 | 12 participants |
| OMS302 Solution | Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 7 | 8 participants |
p-value: 0.824Cochran-Mantel-Haenszel
p-value: 0.476Cochran-Mantel-Haenszel
p-value: 0.281Cochran-Mantel-Haenszel
Secondary
Subjects With Postoperative Ocular Inflammation SOIS = 0, Two Hours Post-surgery
Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/\>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time frame: Two hours
Population: Subjects with scores at time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balanced Salt Solution (BSS) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Two Hours Post-surgery | 1 participants |
| OMS302 Mydriatic Solution (PE) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Two Hours Post-surgery | 3 participants |
| OMS302 Anti-inflammatory Solution (KE) | Subjects With Postoperative Ocular Inflammation SOIS = 0, Two Hours Post-surgery | 1 participants |
| OMS302 Solution | Subjects With Postoperative Ocular Inflammation SOIS = 0, Two Hours Post-surgery | 2 participants |
p-value: 0.559Cochran-Mantel-Haenszel
p-value: 0.647Cochran-Mantel-Haenszel
p-value: 0.559Cochran-Mantel-Haenszel
Secondary
Use of Pain Medications After Day 1
Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: up to 30 days
Population: All randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Use of Pain Medications After Day 1 | Naproxen Sodium | 0 participants |
| Balanced Salt Solution (BSS) | Use of Pain Medications After Day 1 | Celecoxib | 1 participants |
| Balanced Salt Solution (BSS) | Use of Pain Medications After Day 1 | Ibuprofen | 1 participants |
| Balanced Salt Solution (BSS) | Use of Pain Medications After Day 1 | Hydrocodone | 1 participants |
| Balanced Salt Solution (BSS) | Use of Pain Medications After Day 1 | Tramadol | 0 participants |
| Balanced Salt Solution (BSS) | Use of Pain Medications After Day 1 | Axotal | 0 participants |
| Balanced Salt Solution (BSS) | Use of Pain Medications After Day 1 | Tylox | 0 participants |
| Balanced Salt Solution (BSS) | Use of Pain Medications After Day 1 | Paracetamol | 23 participants |
| Balanced Salt Solution (BSS) | Use of Pain Medications After Day 1 | Naproxen | 1 participants |
| Balanced Salt Solution (BSS) | Use of Pain Medications After Day 1 | Diclofenac | 1 participants |
| OMS302 Mydriatic Solution (PE) | Use of Pain Medications After Day 1 | Paracetamol | 21 participants |
| OMS302 Mydriatic Solution (PE) | Use of Pain Medications After Day 1 | Tramadol | 2 participants |
| OMS302 Mydriatic Solution (PE) | Use of Pain Medications After Day 1 | Axotal | 0 participants |
| OMS302 Mydriatic Solution (PE) | Use of Pain Medications After Day 1 | Tylox | 1 participants |
| OMS302 Mydriatic Solution (PE) | Use of Pain Medications After Day 1 | Diclofenac | 0 participants |
| OMS302 Mydriatic Solution (PE) | Use of Pain Medications After Day 1 | Hydrocodone | 0 participants |
| OMS302 Mydriatic Solution (PE) | Use of Pain Medications After Day 1 | Ibuprofen | 0 participants |
| OMS302 Mydriatic Solution (PE) | Use of Pain Medications After Day 1 | Naproxen | 0 participants |
| OMS302 Mydriatic Solution (PE) | Use of Pain Medications After Day 1 | Celecoxib | 0 participants |
| OMS302 Mydriatic Solution (PE) | Use of Pain Medications After Day 1 | Naproxen Sodium | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Use of Pain Medications After Day 1 | Diclofenac | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Use of Pain Medications After Day 1 | Tylox | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Use of Pain Medications After Day 1 | Naproxen Sodium | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Use of Pain Medications After Day 1 | Naproxen | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Use of Pain Medications After Day 1 | Celecoxib | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Use of Pain Medications After Day 1 | Tramadol | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Use of Pain Medications After Day 1 | Hydrocodone | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Use of Pain Medications After Day 1 | Axotal | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Use of Pain Medications After Day 1 | Paracetamol | 20 participants |
| OMS302 Anti-inflammatory Solution (KE) | Use of Pain Medications After Day 1 | Ibuprofen | 0 participants |
| OMS302 Solution | Use of Pain Medications After Day 1 | Tylox | 0 participants |
| OMS302 Solution | Use of Pain Medications After Day 1 | Axotal | 1 participants |
| OMS302 Solution | Use of Pain Medications After Day 1 | Celecoxib | 0 participants |
| OMS302 Solution | Use of Pain Medications After Day 1 | Diclofenac | 0 participants |
| OMS302 Solution | Use of Pain Medications After Day 1 | Hydrocodone | 0 participants |
| OMS302 Solution | Use of Pain Medications After Day 1 | Ibuprofen | 0 participants |
| OMS302 Solution | Use of Pain Medications After Day 1 | Naproxen | 0 participants |
| OMS302 Solution | Use of Pain Medications After Day 1 | Naproxen Sodium | 1 participants |
| OMS302 Solution | Use of Pain Medications After Day 1 | Tramadol | 0 participants |
| OMS302 Solution | Use of Pain Medications After Day 1 | Paracetamol | 29 participants |
p-value: 0.711Cochran-Mantel-Haenszel
p-value: 0.253Cochran-Mantel-Haenszel
p-value: 0.104Cochran-Mantel-Haenszel
Secondary
Use of Pain Medications at Day 1
Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time frame: One day
Population: All randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balanced Salt Solution (BSS) | Use of Pain Medications at Day 1 | Diclofenac | 1 participants |
| Balanced Salt Solution (BSS) | Use of Pain Medications at Day 1 | Ibuprofen | 1 participants |
| Balanced Salt Solution (BSS) | Use of Pain Medications at Day 1 | Paracetamol | 23 participants |
| Balanced Salt Solution (BSS) | Use of Pain Medications at Day 1 | Tramadol | 0 participants |
| Balanced Salt Solution (BSS) | Use of Pain Medications at Day 1 | Axotal | 0 participants |
| Balanced Salt Solution (BSS) | Use of Pain Medications at Day 1 | Naproxen Sodium | 0 participants |
| OMS302 Mydriatic Solution (PE) | Use of Pain Medications at Day 1 | Diclofenac | 0 participants |
| OMS302 Mydriatic Solution (PE) | Use of Pain Medications at Day 1 | Tramadol | 2 participants |
| OMS302 Mydriatic Solution (PE) | Use of Pain Medications at Day 1 | Ibuprofen | 0 participants |
| OMS302 Mydriatic Solution (PE) | Use of Pain Medications at Day 1 | Naproxen Sodium | 0 participants |
| OMS302 Mydriatic Solution (PE) | Use of Pain Medications at Day 1 | Axotal | 0 participants |
| OMS302 Mydriatic Solution (PE) | Use of Pain Medications at Day 1 | Paracetamol | 26 participants |
| OMS302 Anti-inflammatory Solution (KE) | Use of Pain Medications at Day 1 | Naproxen Sodium | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Use of Pain Medications at Day 1 | Paracetamol | 9 participants |
| OMS302 Anti-inflammatory Solution (KE) | Use of Pain Medications at Day 1 | Axotal | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Use of Pain Medications at Day 1 | Diclofenac | 0 participants |
| OMS302 Anti-inflammatory Solution (KE) | Use of Pain Medications at Day 1 | Ibuprofen | 1 participants |
| OMS302 Anti-inflammatory Solution (KE) | Use of Pain Medications at Day 1 | Tramadol | 0 participants |
| OMS302 Solution | Use of Pain Medications at Day 1 | Ibuprofen | 0 participants |
| OMS302 Solution | Use of Pain Medications at Day 1 | Axotal | 1 participants |
| OMS302 Solution | Use of Pain Medications at Day 1 | Paracetamol | 18 participants |
| OMS302 Solution | Use of Pain Medications at Day 1 | Naproxen Sodium | 0 participants |
| OMS302 Solution | Use of Pain Medications at Day 1 | Diclofenac | 0 participants |
| OMS302 Solution | Use of Pain Medications at Day 1 | Tramadol | 0 participants |
p-value: 0.157Cochran-Mantel-Haenszel
p-value: 0.0839Cochran-Mantel-Haenszel
p-value: 0.092Cochran-Mantel-Haenszel