Ocular Inflammation and Pain After Cataract Surgery
Conditions
Brief summary
This Phase 3 study will evaluate APP13007 in comparison to the matching vehicle placebo in a randomized, parallel-group, double-masked fashion. The subjects will have undergone routine cataract surgery on Day 0 of the study and will be assessed the next day (Post-operative Day; POD1) after uncomplicated surgery for eligibility for randomization to study treatment. The study comprises the Main Study and the Endothelial Cell Sub-study.
Interventions
DRUGAPP13007, 0.05%
APP13007 eye drop, 0.05%
Matching vehicle placebo eye drop
Sponsors
Formosa Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years of age or older expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye. * Have a pin-hole corrected visual acuity without other correction of ≤ 1.3 logarithm of the minimum angle of resolution (logMAR) in the study eye to be operated and contralateral eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Visit 1. * Willing and able to comply with study requirements and visit schedule. * Provide signed and dated informed consent.
Exclusion criteria
* Have a known sensitivity or allergy to clobetasol propionate, corticosteroids, or any of the study medication's components including benzalkonium chloride and soybean lecithin or any routine medication required during cataract surgery or for the conduct of study procedures * Have an ACC count \> 0 or any evidence of intraocular inflammation (e.g., flare) in either eye at the Screening visit * Have a Grade \> 0 on the Ocular Pain Assessment in either eye at the Screening visit Note: Other inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Treatment-emergent Adverse Events (AEs) | From First dose to Postoperative Day 22 (End of Main Study) | Number of participants with ocular and systemic treatment-emergent AEs. |
| Participants With ACC Count = 0 in the Operated Study Eye at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication | Postoperative Day 8 and Postoperative Day 15 | The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area. |
| Participants With Ocular Pain Grade = 0 in the Operated Study Eye at All Visits From Postoperative Day 4 Through Postoperative Day 15 Without Rescue Medication | Postoperative Day 4, Postoperative Day 8 and Postoperative Day 15 | Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 1 = minimal; 2 = mild; 3 = moderate; 4 = severe pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD4 Without Rescue Medication | Postoperative Day 4 | Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain). |
| Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication | Postoperative Day 8 | Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain). |
| Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication | Postoperative Day 15 | Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain). |
| Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD4 Without Rescue Medication | Postoperative Day 4 | The degree of turbidity (flare) in the anterior chamber of the eye is measured using slit-lamp biomicroscopy and quantified on a five-point (0-4) anterior chamber flare grade scale (0 = none; 4 = Intense). |
| Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD8 Without Rescue Medication | Postoperative Day 8 | The degree of turbidity (flare) in the anterior chamber of the eye is measured using slit-lamp biomicroscopy and quantified on a five-point (0-4) anterior chamber flare grade scale (0 = none; 4 = Intense). |
| Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD15 Without Rescue Medication | Postoperative Day 15 | The degree of turbidity (flare) in the anterior chamber of the eye is measured using slit-lamp biomicroscopy and quantified on a five-point (0-4) anterior chamber flare grade scale (0 = none; 4 = Intense). |
| Ocular Pain Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15 | Baseline and Postoperative Day 15 | Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 1 = minimal; 2 = mild; 3 = moderate; 4 = severe pain). |
| Anterior Chamber Flare (ACF) in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15 | Baseline and Postoperative Day 15 | The degree of turbidity (flare) in the anterior chamber of the eye is measured using slit-lamp biomicroscopy and quantified on a five-point (0-4) anterior chamber flare grade scale (0 = none; 1 = faint; 2 = moderate; 3 = marked; 4 = Intense). |
| Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD4 | Baseline and Postoperative Day 4 | The visual acuity in each eye is corrected using the pinhole method and the acuity is quantified on a logMAR (minimal angle of resolution) scale using the 'Early Treatment Diabetic Retinopathy Study' \[ETDRS\] charts for right and left eyes. A logMAR Score is calculated using the letter row on the chart and the number of incorrect letters read by the participant. |
| Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD8 | Baseline and Postoperative Day 8 | The visual acuity in each eye is corrected using the pinhole method and the acuity is quantified on a logMAR (minimal angle of resolution) scale using the 'Early Treatment Diabetic Retinopathy Study' \[ETDRS\] charts for right and left eyes. A logMAR Score is calculated using the letter row on the chart and the number of incorrect letters read by the participant. |
| Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD15 | Baseline and Postoperative Day 15 | The visual acuity in each eye is corrected using the pinhole method and the acuity is quantified on a logMAR (minimal angle of resolution) scale using the 'Early Treatment Diabetic Retinopathy Study' \[ETDRS\] charts for right and left eyes. A logMAR Score is calculated using the letter row on the chart and the number of incorrect letters read by the participant. |
| Participants Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment | First dose to Postoperative Day 15 | Participants who do not respond to study treatment after randomization are started on anti-inflammatory medication (referred to as 'Rescue' medication). The number of subjects starting 'Rescue' medication is recorded at each study visit |
| Anterior Chamber Cell Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15 | Baseline and Postoperative Day 15 | The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy and the results are reported as number of cells in a 1mm x 1mm area using a 5 point grading scale. ACC Grade 0 = 0 cells, ACC grade 1 = 1-5 cells, ACC grade 2 = 6-15 cells, ACC grade 3 = 16-30 cells, ACC grade 4 = \>30 cells |
| Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication | Postoperative Day 8 | The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area.ACC Grade 0 = 0 cells, ACC grade 1 = 1-5 cells, ACC grade 2 = 6-15 cells, ACC grade 3 = 16-30 cells, ACC grade 4 = \>30 cells. |
| Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication | Postoperative Day 15 | The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area. ACC Grade 0 = 0 cells, ACC grade 1 = 1-5 cells, ACC grade 2 = 6-15 cells, ACC grade 3 = 16-30 cells, ACC grade 4 = \>30 cells. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Corneal Endothelial Cell Density - Mean Change From Screening to Postoperative Day 85 | Screening and Postoperative Day 85 | Corneal endothelial cell density in the Operated Study Eye (units: cells/mm2) was measured from the corneal endothelial cell images obtained using a specular microscope. |
Countries
United States
Participant flow
Recruitment details
A multi-center US study in which 29 sites recruited subjects between March 2021 and March 2022.
Pre-assignment details
Pre-assignment Details Of 466 enrolled participants, 370 met inclusion criteria and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| APP13007 0.05% BID 1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05% | 185 |
| Matching Vehicle Placebo 1 drop matching vehicle placebo twice daily for 14 days to study (operated) eye
Matching Vehicle Placebo for APP13007, 0.05%: Matching vehicle placebo eye drop | 185 |
| Total | 370 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | IP NOT AVAILABLE; REMAINED OUT OF THE COUNTRY; NON STUDY EYE NOT ELIGIBLE ON ENDOTHELIAL CELL COUNT | 2 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | APP13007 0.05% BID | Total | Matching Vehicle Placebo |
|---|---|---|---|
| Age, Continuous | 67.2 Years STANDARD_DEVIATION 9.7 | 67.6 Years STANDARD_DEVIATION 9.1 | 68.0 Years STANDARD_DEVIATION 8.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants | 73 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 147 Participants | 297 Participants | 150 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 32 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 42 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 150 Participants | 295 Participants | 145 Participants |
| Region of Enrollment United States | 185 participants | 370 participants | 185 participants |
| Sex: Female, Male Female | 98 Participants | 195 Participants | 97 Participants |
| Sex: Female, Male Male | 87 Participants | 175 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 184 | 0 / 185 |
| other Total, other adverse events | 6 / 184 | 14 / 185 |
| serious Total, serious adverse events | 1 / 184 | 4 / 185 |
Outcome results
Primary
Participants With ACC Count = 0 in the Operated Study Eye at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication
The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area.
Time frame: Postoperative Day 8 and Postoperative Day 15
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APP13007 0.05% BID | Participants With ACC Count = 0 in the Operated Study Eye at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication | 49 Participants |
| Matching Vehicle Placebo | Participants With ACC Count = 0 in the Operated Study Eye at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication | 16 Participants |
p-value: <0.001Chi-squared
Primary
Participants With Ocular Pain Grade = 0 in the Operated Study Eye at All Visits From Postoperative Day 4 Through Postoperative Day 15 Without Rescue Medication
Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 1 = minimal; 2 = mild; 3 = moderate; 4 = severe pain).
Time frame: Postoperative Day 4, Postoperative Day 8 and Postoperative Day 15
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APP13007 0.05% BID | Participants With Ocular Pain Grade = 0 in the Operated Study Eye at All Visits From Postoperative Day 4 Through Postoperative Day 15 Without Rescue Medication | 139 Participants |
| Matching Vehicle Placebo | Participants With Ocular Pain Grade = 0 in the Operated Study Eye at All Visits From Postoperative Day 4 Through Postoperative Day 15 Without Rescue Medication | 60 Participants |
p-value: <0.001Chi-squared
Primary
Participants With Treatment-emergent Adverse Events (AEs)
Number of participants with ocular and systemic treatment-emergent AEs.
Time frame: From First dose to Postoperative Day 22 (End of Main Study)
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APP13007 0.05% BID | Participants With Treatment-emergent Adverse Events (AEs) | 47 Participants |
| Matching Vehicle Placebo | Participants With Treatment-emergent Adverse Events (AEs) | 48 Participants |
Secondary
Anterior Chamber Cell Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15
The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy and the results are reported as number of cells in a 1mm x 1mm area using a 5 point grading scale. ACC Grade 0 = 0 cells, ACC grade 1 = 1-5 cells, ACC grade 2 = 6-15 cells, ACC grade 3 = 16-30 cells, ACC grade 4 = \>30 cells
Time frame: Baseline and Postoperative Day 15
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| APP13007 0.05% BID | Anterior Chamber Cell Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15 | -2.1 grade on a scale | Standard Error 0.1 |
| Matching Vehicle Placebo | Anterior Chamber Cell Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15 | -1.0 grade on a scale | Standard Error 0.1 |
p-value: <0.00195% CI: [-1.4, -1]ANCOVA
Secondary
Anterior Chamber Flare (ACF) in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15
The degree of turbidity (flare) in the anterior chamber of the eye is measured using slit-lamp biomicroscopy and quantified on a five-point (0-4) anterior chamber flare grade scale (0 = none; 1 = faint; 2 = moderate; 3 = marked; 4 = Intense).
Time frame: Baseline and Postoperative Day 15
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| APP13007 0.05% BID | Anterior Chamber Flare (ACF) in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15 | -0.6 grade on a scale | Standard Error 0 |
| Matching Vehicle Placebo | Anterior Chamber Flare (ACF) in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15 | -0.2 grade on a scale | Standard Error 0 |
p-value: <0.00195% CI: [-0.5, -0.3]ANCOVA
Secondary
Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD15
The visual acuity in each eye is corrected using the pinhole method and the acuity is quantified on a logMAR (minimal angle of resolution) scale using the 'Early Treatment Diabetic Retinopathy Study' \[ETDRS\] charts for right and left eyes. A logMAR Score is calculated using the letter row on the chart and the number of incorrect letters read by the participant.
Time frame: Baseline and Postoperative Day 15
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| APP13007 0.05% BID | Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD15 | -0.10 logMAR score | Standard Error 0.01 |
| Matching Vehicle Placebo | Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD15 | -0.02 logMAR score | Standard Error 0.01 |
p-value: <0.00195% CI: [-0.11, -0.05]ANCOVA
Secondary
Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD4
The visual acuity in each eye is corrected using the pinhole method and the acuity is quantified on a logMAR (minimal angle of resolution) scale using the 'Early Treatment Diabetic Retinopathy Study' \[ETDRS\] charts for right and left eyes. A logMAR Score is calculated using the letter row on the chart and the number of incorrect letters read by the participant.
Time frame: Baseline and Postoperative Day 4
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| APP13007 0.05% BID | Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD4 | -0.08 logMAR Score | Standard Error 0.01 |
| Matching Vehicle Placebo | Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD4 | -0.03 logMAR Score | Standard Error 0.01 |
p-value: <0.00195% CI: [-0.07, -0.02]ANCOVA
Secondary
Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD8
The visual acuity in each eye is corrected using the pinhole method and the acuity is quantified on a logMAR (minimal angle of resolution) scale using the 'Early Treatment Diabetic Retinopathy Study' \[ETDRS\] charts for right and left eyes. A logMAR Score is calculated using the letter row on the chart and the number of incorrect letters read by the participant.
Time frame: Baseline and Postoperative Day 8
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| APP13007 0.05% BID | Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD8 | -0.11 logMAR score | Standard Error 0.01 |
| Matching Vehicle Placebo | Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD8 | -0.03 logMAR score | Standard Error 0.01 |
p-value: <0.00195% CI: [-0.1, -0.05]ANCOVA
Secondary
Ocular Pain Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15
Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 1 = minimal; 2 = mild; 3 = moderate; 4 = severe pain).
Time frame: Baseline and Postoperative Day 15
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| APP13007 0.05% BID | Ocular Pain Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15 | -0.6 grade on a scale | Standard Error 0.1 |
| Matching Vehicle Placebo | Ocular Pain Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15 | -0.1 grade on a scale | Standard Error 0.1 |
p-value: <0.00195% CI: [-0.7, -0.3]ANCOVA
Secondary
Participants Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment
Participants who do not respond to study treatment after randomization are started on anti-inflammatory medication (referred to as 'Rescue' medication). The number of subjects starting 'Rescue' medication is recorded at each study visit
Time frame: First dose to Postoperative Day 15
Population: Intent to Treat Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APP13007 0.05% BID | Participants Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment | 13 Participants |
| Matching Vehicle Placebo | Participants Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment | 71 Participants |
p-value: <0.001Chi-squared
Secondary
Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication
The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area. ACC Grade 0 = 0 cells, ACC grade 1 = 1-5 cells, ACC grade 2 = 6-15 cells, ACC grade 3 = 16-30 cells, ACC grade 4 = \>30 cells.
Time frame: Postoperative Day 15
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APP13007 0.05% BID | Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication | 107 Participants |
| Matching Vehicle Placebo | Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication | 35 Participants |
p-value: <0.001Chi-squared
Secondary
Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication
The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area.ACC Grade 0 = 0 cells, ACC grade 1 = 1-5 cells, ACC grade 2 = 6-15 cells, ACC grade 3 = 16-30 cells, ACC grade 4 = \>30 cells.
Time frame: Postoperative Day 8
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APP13007 0.05% BID | Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication | 55 Participants |
| Matching Vehicle Placebo | Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication | 24 Participants |
p-value: <0.001Chi-squared
Secondary
Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD15 Without Rescue Medication
The degree of turbidity (flare) in the anterior chamber of the eye is measured using slit-lamp biomicroscopy and quantified on a five-point (0-4) anterior chamber flare grade scale (0 = none; 4 = Intense).
Time frame: Postoperative Day 15
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APP13007 0.05% BID | Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD15 Without Rescue Medication | 159 Participants |
| Matching Vehicle Placebo | Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD15 Without Rescue Medication | 79 Participants |
p-value: <0.001Chi-squared
Secondary
Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD4 Without Rescue Medication
The degree of turbidity (flare) in the anterior chamber of the eye is measured using slit-lamp biomicroscopy and quantified on a five-point (0-4) anterior chamber flare grade scale (0 = none; 4 = Intense).
Time frame: Postoperative Day 4
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APP13007 0.05% BID | Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD4 Without Rescue Medication | 132 Participants |
| Matching Vehicle Placebo | Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD4 Without Rescue Medication | 89 Participants |
p-value: <0.001Chi-squared
Secondary
Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD8 Without Rescue Medication
The degree of turbidity (flare) in the anterior chamber of the eye is measured using slit-lamp biomicroscopy and quantified on a five-point (0-4) anterior chamber flare grade scale (0 = none; 4 = Intense).
Time frame: Postoperative Day 8
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APP13007 0.05% BID | Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD8 Without Rescue Medication | 155 Participants |
| Matching Vehicle Placebo | Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD8 Without Rescue Medication | 90 Participants |
p-value: <0.001Chi-squared
Secondary
Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication
Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).
Time frame: Postoperative Day 15
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APP13007 0.05% BID | Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication | 160 Participants |
| Matching Vehicle Placebo | Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication | 92 Participants |
p-value: <0.001Chi-squared
Secondary
Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD4 Without Rescue Medication
Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).
Time frame: Postoperative Day 4
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APP13007 0.05% BID | Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD4 Without Rescue Medication | 158 Participants |
| Matching Vehicle Placebo | Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD4 Without Rescue Medication | 95 Participants |
p-value: <0.001Chi-squared
Secondary
Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication
Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).
Time frame: Postoperative Day 8
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APP13007 0.05% BID | Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication | 161 Participants |
| Matching Vehicle Placebo | Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication | 86 Participants |
p-value: <0.001Chi-squared
Other Pre-specified
Corneal Endothelial Cell Density - Mean Change From Screening to Postoperative Day 85
Corneal endothelial cell density in the Operated Study Eye (units: cells/mm2) was measured from the corneal endothelial cell images obtained using a specular microscope.
Time frame: Screening and Postoperative Day 85
Population: Safety Population for Sub-study Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APP13007 0.05% BID | Corneal Endothelial Cell Density - Mean Change From Screening to Postoperative Day 85 | -276 cells/mm2 | Standard Deviation 408 |
| Matching Vehicle Placebo | Corneal Endothelial Cell Density - Mean Change From Screening to Postoperative Day 85 | -354 cells/mm2 | Standard Deviation 437 |