Ocular Inflammation and Pain
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 1; POD1) after uncomplicated surgery for eligibility for randomization to study treatment.
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 ACC Count = 0 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 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 each 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). |
| Participants With Treatment-emergent Adverse Events (AEs) | From First dose to Postoperative Day 22 | Number of participants with ocular and systemic treatment-emergent AEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Ocular Pain Grade = 0 at POD8 Without Rescue Medication | Postoperative Day 8 | Ocular pain is measured in each 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 at POD15 Without Rescue Medication | Postoperative Day 15 | Ocular pain is measured in each 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 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 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 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). |
| Anterior Chamber Cell Grade - 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 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 |
| Anterior Chamber Flare (ACF) - 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; 4 = Intense). |
| Best Corrected Visual Acuity - 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 - 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 - 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 |
| Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD 15 | Baseline and Postoperative Day 15 | Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain). |
| Participants With Anterior Chamber Cell Grade = 0 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 |
| Participants With Ocular Pain Grade = 0 at POD4 Without Rescue Medication | Postoperative Day 4 | Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain). |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
A multi-center US study in which 27 sites recruited subjects between January 2021 and February 2022.
Pre-assignment details
Of 456 enrolled participants, 378 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% | 181 |
| Matching Vehicle Placebo 1 drop matching vehicle place twice daily for 14 days to study (operated) eye
Matching Vehicle Placebo for APP13007, 0.05%: Matching vehicle placebo eye drop | 197 |
| Total | 378 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | APP13007 0.05% BID | Total | Matching Vehicle Placebo |
|---|---|---|---|
| Age, Continuous | 68.7 Years STANDARD_DEVIATION 8.9 | 68.3 Years STANDARD_DEVIATION 8.7 | 67.8 Years STANDARD_DEVIATION 8.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 35 Participants | 87 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 146 Participants | 291 Participants | 145 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 27 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 45 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 150 Participants | 301 Participants | 151 Participants |
| Region of Enrollment United States | 181 participants | 378 participants | 197 participants |
| Sex: Female, Male Female | 106 Participants | 225 Participants | 119 Participants |
| Sex: Female, Male Male | 75 Participants | 153 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 181 | 0 / 197 |
| other Total, other adverse events | 3 / 181 | 10 / 197 |
| serious Total, serious adverse events | 0 / 181 | 0 / 197 |
Outcome results
Primary
Participants With ACC Count = 0 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 at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication | 48 Participants |
| Matching Vehicle Placebo | Participants With ACC Count = 0 at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication | 10 Participants |
p-value: <0.001Chi-squared
Primary
Participants With Ocular Pain Grade = 0 at All Visits From Postoperative Day 4 Through Postoperative Day 15 Without Rescue Medication
Ocular pain is measured in each 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 at All Visits From Postoperative Day 4 Through Postoperative Day 15 Without Rescue Medication | 123 Participants |
| Matching Vehicle Placebo | Participants With Ocular Pain Grade = 0 at All Visits From Postoperative Day 4 Through Postoperative Day 15 Without Rescue Medication | 46 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
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APP13007 0.05% BID | Participants With Treatment-emergent Adverse Events (AEs) | 38 Participants |
| Matching Vehicle Placebo | Participants With Treatment-emergent Adverse Events (AEs) | 39 Participants |
Secondary
Anterior Chamber Cell Grade - 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 - 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 - Change From Baseline (POD1 Prior to Dosing) to POD 15 | -0.6 grade on a scale | Standard Error 0.1 |
p-value: <0.00195% CI: [-1.8, -1.3]ANCOVA
Secondary
Anterior Chamber Flare (ACF) - 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; 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) - Change From Baseline (POD1 Prior to Dosing) to POD 15 | -0.7 grade on a scale | Standard Error 0.1 |
| Matching Vehicle Placebo | Anterior Chamber Flare (ACF) - Change From Baseline (POD1 Prior to Dosing) to POD 15 | -0.0 grade on a scale | Standard Error 0 |
p-value: <0.00195% CI: [-0.8, -0.5]ANCOVA
Secondary
Best Corrected Visual Acuity - 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 - Change From Baseline (POD1 Prior to Dosing) to POD15 | -0.11 logMAR score | Standard Error 0.01 |
| Matching Vehicle Placebo | Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD15 | -0.02 logMAR score | Standard Error 0.01 |
p-value: <0.00195% CI: [-0.11, -0.06]ANCOVA
Secondary
Best Corrected Visual Acuity - 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 - Change From Baseline (POD1 Prior to Dosing) to POD4 | -0.07 logMAR score | Standard Error 0.01 |
| Matching Vehicle Placebo | Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD4 | -0.04 logMAR score | Standard Error 0.01 |
p-value: 0.01795% CI: [-0.06, -0.01]ANCOVA
Secondary
Best Corrected Visual Acuity - 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 - Change From Baseline (POD1 Prior to Dosing) to POD8 | -0.10 logMAR score | Standard Error 0.01 |
| Matching Vehicle Placebo | Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD8 | -0.02 logMAR score | Standard Error 0.01 |
p-value: <0.00195% CI: [-0.1, -0.04]ANCOVA
Secondary
Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD 15
Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 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 - Change From Baseline (POD1 Prior to Dosing) to POD 15 | -1.1 grade on a scale | Standard Error 0.1 |
| Matching Vehicle Placebo | Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD 15 | -0.3 grade on a scale | Standard Error 0.1 |
p-value: <0.00195% CI: [-0.9, -0.6]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 | 10 Participants |
| Matching Vehicle Placebo | Participants Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment | 100 Participants |
p-value: <0.001Chi-squared
Secondary
Participants With Anterior Chamber Cell Grade = 0 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 at POD15 Without Rescue Medication | 106 Participants |
| Matching Vehicle Placebo | Participants With Anterior Chamber Cell Grade = 0 at POD15 Without Rescue Medication | 31 Participants |
p-value: <0.001Chi-squared
Secondary
Participants With Anterior Chamber Cell Grade = 0 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 at POD8 Without Rescue Medication | 59 Participants |
| Matching Vehicle Placebo | Participants With Anterior Chamber Cell Grade = 0 at POD8 Without Rescue Medication | 23 Participants |
p-value: <0.001Chi-squared
Secondary
Participants With Anterior Chamber Flare (ACF) = 0 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 at POD15 Without Rescue Medication | 159 Participants |
| Matching Vehicle Placebo | Participants With Anterior Chamber Flare (ACF) = 0 at POD15 Without Rescue Medication | 65 Participants |
p-value: <0.001Chi-squared
Secondary
Participants With Anterior Chamber Flare (ACF) = 0 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 at POD4 Without Rescue Medication | 111 Participants |
| Matching Vehicle Placebo | Participants With Anterior Chamber Flare (ACF) = 0 at POD4 Without Rescue Medication | 79 Participants |
p-value: <0.001Chi-squared
Secondary
Participants With Anterior Chamber Flare (ACF) = 0 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 at POD8 Without Rescue Medication | 142 Participants |
| Matching Vehicle Placebo | Participants With Anterior Chamber Flare (ACF) = 0 at POD8 Without Rescue Medication | 75 Participants |
p-value: <0.001Chi-squared
Secondary
Participants With Ocular Pain Grade = 0 at POD15 Without Rescue Medication
Ocular pain is measured in each 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 at POD15 Without Rescue Medication | 164 Participants |
| Matching Vehicle Placebo | Participants With Ocular Pain Grade = 0 at POD15 Without Rescue Medication | 83 Participants |
p-value: <0.001Chi-squared
Secondary
Participants With Ocular Pain Grade = 0 at POD4 Without Rescue Medication
Ocular pain is measured in each 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 at POD4 Without Rescue Medication | 140 Participants |
| Matching Vehicle Placebo | Participants With Ocular Pain Grade = 0 at POD4 Without Rescue Medication | 86 Participants |
p-value: <0.001Chi-squared
Secondary
Participants With Ocular Pain Grade = 0 at POD8 Without Rescue Medication
Ocular pain is measured in each 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 at POD8 Without Rescue Medication | 149 Participants |
| Matching Vehicle Placebo | Participants With Ocular Pain Grade = 0 at POD8 Without Rescue Medication | 84 Participants |
p-value: <0.001Chi-squared