Trial Outcomes & Findings for Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study (NCT NCT04810962)
NCT ID: NCT04810962
Last Updated: 2023-07-25
Results Overview
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.
COMPLETED
PHASE3
370 participants
Postoperative Day 8 and Postoperative Day 15
2023-07-25
Participant Flow
A multi-center US study in which 29 sites recruited subjects between March 2021 and March 2022.
Pre-assignment Details Of 466 enrolled participants, 370 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
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%
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
185
|
185
|
|
Overall Study
COMPLETED
|
179
|
179
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
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%
|
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
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
IP NOT AVAILABLE; REMAINED OUT OF THE COUNTRY; NON STUDY EYE NOT ELIGIBLE ON ENDOTHELIAL CELL COUNT
|
2
|
1
|
Baseline Characteristics
Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study
Baseline characteristics by cohort
| Measure |
APP13007 0.05% BID
n=185 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 Participants
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
|
Total
n=370 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
150 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
185 participants
n=5 Participants
|
185 participants
n=7 Participants
|
370 participants
n=5 Participants
|
|
Age, Continuous
|
67.2 Years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
68.0 Years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
67.6 Years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
147 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Postoperative Day 8 and Postoperative Day 15Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
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.
Outcome measures
| Measure |
APP13007 0.05% BID
n=185 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 Participants
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
|
|---|---|---|
|
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
|
16 Participants
|
PRIMARY outcome
Timeframe: Postoperative Day 4, Postoperative Day 8 and Postoperative Day 15Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
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).
Outcome measures
| Measure |
APP13007 0.05% BID
n=185 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 Participants
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
|
|---|---|---|
|
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
|
60 Participants
|
PRIMARY outcome
Timeframe: From First dose to Postoperative Day 22 (End of Main Study)Population: Safety Population
Number of participants with ocular and systemic treatment-emergent AEs.
Outcome measures
| Measure |
APP13007 0.05% BID
n=184 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 Participants
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
|
|---|---|---|
|
Participants With Treatment-emergent Adverse Events (AEs)
|
47 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Postoperative Day 8Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
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.
Outcome measures
| Measure |
APP13007 0.05% BID
n=185 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 Participants
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
|
|---|---|---|
|
Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication
|
55 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Postoperative Day 15Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
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.
Outcome measures
| Measure |
APP13007 0.05% BID
n=185 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 Participants
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
|
|---|---|---|
|
Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication
|
107 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Postoperative Day 4Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
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).
Outcome measures
| Measure |
APP13007 0.05% BID
n=185 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 Participants
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
|
|---|---|---|
|
Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD4 Without Rescue Medication
|
158 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: Postoperative Day 8Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
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).
Outcome measures
| Measure |
APP13007 0.05% BID
n=185 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 Participants
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
|
|---|---|---|
|
Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication
|
161 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: Postoperative Day 15Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
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).
Outcome measures
| Measure |
APP13007 0.05% BID
n=185 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 Participants
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
|
|---|---|---|
|
Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication
|
160 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: Postoperative Day 4Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
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).
Outcome measures
| Measure |
APP13007 0.05% BID
n=185 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 Participants
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
|
|---|---|---|
|
Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD4 Without Rescue Medication
|
132 Participants
|
89 Participants
|
SECONDARY outcome
Timeframe: Postoperative Day 8Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
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).
Outcome measures
| Measure |
APP13007 0.05% BID
n=185 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 Participants
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
|
|---|---|---|
|
Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD8 Without Rescue Medication
|
155 Participants
|
90 Participants
|
SECONDARY outcome
Timeframe: Postoperative Day 15Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
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).
Outcome measures
| Measure |
APP13007 0.05% BID
n=185 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 Participants
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
|
|---|---|---|
|
Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD15 Without Rescue Medication
|
159 Participants
|
79 Participants
|
SECONDARY outcome
Timeframe: Baseline and Postoperative Day 15Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
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
Outcome measures
| Measure |
APP13007 0.05% BID
n=185 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 Participants
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
|
|---|---|---|
|
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
|
-1.0 grade on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline and Postoperative Day 15Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
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).
Outcome measures
| Measure |
APP13007 0.05% BID
n=185 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 Participants
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
|
|---|---|---|
|
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
|
-0.1 grade on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline and Postoperative Day 15Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
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).
Outcome measures
| Measure |
APP13007 0.05% BID
n=185 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 Participants
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
|
|---|---|---|
|
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 0.0
|
-0.2 grade on a scale
Standard Error 0.0
|
SECONDARY outcome
Timeframe: Baseline and Postoperative Day 4Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
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.
Outcome measures
| Measure |
APP13007 0.05% BID
n=185 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 Participants
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
|
|---|---|---|
|
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
|
-0.03 logMAR Score
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Baseline and Postoperative Day 8Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
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.
Outcome measures
| Measure |
APP13007 0.05% BID
n=185 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 Participants
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
|
|---|---|---|
|
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
|
-0.03 logMAR score
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Baseline and Postoperative Day 15Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
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.
Outcome measures
| Measure |
APP13007 0.05% BID
n=185 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 Participants
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
|
|---|---|---|
|
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
|
-0.02 logMAR score
Standard Error 0.01
|
SECONDARY outcome
Timeframe: First dose to Postoperative Day 15Population: Intent to Treat Population.
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
Outcome measures
| Measure |
APP13007 0.05% BID
n=185 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 Participants
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
|
|---|---|---|
|
Participants Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment
|
13 Participants
|
71 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening and Postoperative Day 85Population: Safety Population for Sub-study Participants
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.
Outcome measures
| Measure |
APP13007 0.05% BID
n=66 Participants
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=70 Participants
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
|
|---|---|---|
|
Corneal Endothelial Cell Density - Mean Change From Screening to Postoperative Day 85
|
-276 cells/mm2
Standard Deviation 408
|
-354 cells/mm2
Standard Deviation 437
|
Adverse Events
APP13007 0.05% BID
Matching Vehicle Placebo
Serious adverse events
| Measure |
APP13007 0.05% BID
n=184 participants at risk
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 participants at risk
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
|
|---|---|---|
|
Eye disorders
Cystoid macular oedema
|
0.54%
1/184 • Number of events 1 • All-Cause Mortality data were collected from informed consent through Postoperative Day 85. Serious adverse events were collected from informed consent through Postoperative Day 85. Other (not Including Serious) adverse events were collected from the first dose through Postoperative Day 22 (end of Main Study).
|
1.6%
3/185 • Number of events 3 • All-Cause Mortality data were collected from informed consent through Postoperative Day 85. Serious adverse events were collected from informed consent through Postoperative Day 85. Other (not Including Serious) adverse events were collected from the first dose through Postoperative Day 22 (end of Main Study).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/184 • All-Cause Mortality data were collected from informed consent through Postoperative Day 85. Serious adverse events were collected from informed consent through Postoperative Day 85. Other (not Including Serious) adverse events were collected from the first dose through Postoperative Day 22 (end of Main Study).
|
0.54%
1/185 • Number of events 1 • All-Cause Mortality data were collected from informed consent through Postoperative Day 85. Serious adverse events were collected from informed consent through Postoperative Day 85. Other (not Including Serious) adverse events were collected from the first dose through Postoperative Day 22 (end of Main Study).
|
|
Nervous system disorders
Syncope
|
0.00%
0/184 • All-Cause Mortality data were collected from informed consent through Postoperative Day 85. Serious adverse events were collected from informed consent through Postoperative Day 85. Other (not Including Serious) adverse events were collected from the first dose through Postoperative Day 22 (end of Main Study).
|
0.54%
1/185 • Number of events 1 • All-Cause Mortality data were collected from informed consent through Postoperative Day 85. Serious adverse events were collected from informed consent through Postoperative Day 85. Other (not Including Serious) adverse events were collected from the first dose through Postoperative Day 22 (end of Main Study).
|
Other adverse events
| Measure |
APP13007 0.05% BID
n=184 participants at risk
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
APP13007, 0.05%: APP13007 eye drop, 0.05%
|
Matching Vehicle Placebo
n=185 participants at risk
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
|
|---|---|---|
|
Eye disorders
Eye inflammation
|
3.3%
6/184 • Number of events 6 • All-Cause Mortality data were collected from informed consent through Postoperative Day 85. Serious adverse events were collected from informed consent through Postoperative Day 85. Other (not Including Serious) adverse events were collected from the first dose through Postoperative Day 22 (end of Main Study).
|
7.6%
14/185 • Number of events 14 • All-Cause Mortality data were collected from informed consent through Postoperative Day 85. Serious adverse events were collected from informed consent through Postoperative Day 85. Other (not Including Serious) adverse events were collected from the first dose through Postoperative Day 22 (end of Main Study).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Institutions and Investigators participating in this trial shall have no right to publish or present the results of this study without the prior written consent of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER