| 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. | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | | Count of Participants | | Participants | | Postoperative Day 8 and Postoperative Day 15 | | | | ID | Title | Description |
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| OG000 | 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% | | OG001 | 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 |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Chi-squared | | <0.001 | | | | | | | | | | | | | | Superiority | | |
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| 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). | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | | Count of Participants | | Participants | | Postoperative Day 4, Postoperative Day 8 and Postoperative Day 15 | | | | ID | Title | Description |
|---|
| OG000 | 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% | | OG001 | 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 |
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| Primary | Participants With Treatment-emergent Adverse Events (AEs) | Number of participants with ocular and systemic treatment-emergent AEs. | | Posted | | Count of Participants | | Participants | | From First dose to Postoperative Day 22 (End of Main Study) | | | | ID | Title | Description |
|---|
| OG000 | 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% | | OG001 | 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 |
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| 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. | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | | Count of Participants | | Participants | | Postoperative Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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% | | OG001 | 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 |
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| 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. | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | | Count of Participants | | Participants | | Postoperative Day 15 | | | | ID | Title | Description |
|---|
| OG000 | 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% | | OG001 | 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 |
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| 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). | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | | Count of Participants | | Participants | | Postoperative Day 4 | | | | ID | Title | Description |
|---|
| OG000 | 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% | | OG001 | 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 |
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| 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). | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | | Count of Participants | | Participants | | Postoperative Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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% | | OG001 | 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 |
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| 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). | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | | Count of Participants | | Participants | | Postoperative Day 15 | | | | ID | Title | Description |
|---|
| OG000 | 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% | | OG001 | 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 |
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| 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). | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | | Count of Participants | | Participants | | Postoperative Day 4 | | | | ID | Title | Description |
|---|
| OG000 | 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% | | OG001 | 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 |
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| 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). | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | | Count of Participants | | Participants | | Postoperative Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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% | | OG001 | 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 |
| |
| 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). | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | | Count of Participants | | Participants | | Postoperative Day 15 | | | | ID | Title | Description |
|---|
| OG000 | 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% | | OG001 | 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 |
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| 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 | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | | Least Squares Mean | Standard Error | grade on a scale | | Baseline and Postoperative Day 15 | | | | ID | Title | Description |
|---|
| OG000 | 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% | | OG001 | 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 |
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| 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). | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | | Least Squares Mean | Standard Error | grade on a scale | | Baseline and Postoperative Day 15 | | | | ID | Title | Description |
|---|
| OG000 | 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% | | OG001 | 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 |
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| 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). | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | | Least Squares Mean | Standard Error | grade on a scale | | Baseline and Postoperative Day 15 | | | | ID | Title | Description |
|---|
| OG000 | 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% | | OG001 | 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 |
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| 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. | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | | Least Squares Mean | Standard Error | logMAR Score | | Baseline and Postoperative Day 4 | | | | ID | Title | Description |
|---|
| OG000 | 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% | | OG001 | 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 |
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| 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. | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | | Least Squares Mean | Standard Error | logMAR score | | Baseline and Postoperative Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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% | | OG001 | 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 |
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| 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. | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | | Least Squares Mean | Standard Error | logMAR score | | Baseline and Postoperative Day 15 | | | | ID | Title | Description |
|---|
| OG000 | 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% | | OG001 | 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 |
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| 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 | Intent to Treat Population. | Posted | | Count of Participants | | Participants | | First dose to Postoperative Day 15 | | | | ID | Title | Description |
|---|
| OG000 | 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% | | OG001 | 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 |
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| 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. | Safety Population for Sub-study Participants | Posted | | Mean | Standard Deviation | cells/mm2 | | Screening and Postoperative Day 85 | | | | ID | Title | Description |
|---|
| OG000 | 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% | | OG001 | 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 |
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