Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery (NCT NCT04089735)

Results Overview

Number of treatment emergent adverse events and number of participants.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

165 participants

Primary outcome timeframe

From First dose to Post-operative Day 28 (Part A) or Day 22 (Part B)

Results posted on

2023-06-27

Participant Flow

A multi-center US study in which 9 sites recruited subjects between August 2019 and October 2019 for Study Part A and between November 2019 and February 2020 for Study Part B

Of 52 enrolled participants for Part A, 45 met inclusion criteria and were randomized to treatment. Of 113 enrolled participants for Part B, 87 met inclusion criteria and were randomized to treatment.

Participant milestones

Participant milestones
Measure	APP13007 0.05% Twice Daily (BID) 1 drop 0.05% APP13007 twice daily for 21 days to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.05% Twice Daily (BID) and Once Daily (QD) 1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) 1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.1% Twice Daily (BID) and Once Daily (QD) 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1%	APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%
Overall Study STARTED	22	23	22	22	22	21
Overall Study COMPLETED	21	17	20	16	21	15
Overall Study NOT COMPLETED	1	6	2	6	1	6

Reasons for withdrawal

Reasons for withdrawal
Measure	APP13007 0.05% Twice Daily (BID) 1 drop 0.05% APP13007 twice daily for 21 days to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.05% Twice Daily (BID) and Once Daily (QD) 1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) 1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.1% Twice Daily (BID) and Once Daily (QD) 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1%	APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%
Overall Study Adverse Event	1	0	1	1	0	0
Overall Study Physician Decision	0	3	0	0	0	0
Overall Study Withdrawal by Subject	0	0	1	0	0	0
Overall Study Rescue therapy, prohibited medication, withdrawn requiring alternate medication for inflammation	0	3	0	5	1	6

Baseline Characteristics

A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	APP13007 0.05% Twice Daily (BID) n=22 Participants 1 drop 0.05% APP13007 twice daily for 21 days to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) n=23 Participants 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.05% Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.1% Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1%	APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) n=21 Participants 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%	Total n=132 Participants Total of all reporting groups
Age, Continuous	69.1 years STANDARD_DEVIATION 8.6 • n=5 Participants	66.3 years STANDARD_DEVIATION 6.6 • n=7 Participants	66.8 years STANDARD_DEVIATION 6.6 • n=5 Participants	70.0 years STANDARD_DEVIATION 5.0 • n=4 Participants	70.0 years STANDARD_DEVIATION 6.0 • n=21 Participants	65.2 years STANDARD_DEVIATION 6.3 • n=10 Participants	67.9 years STANDARD_DEVIATION 6.7 • n=115 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	15 Participants n=7 Participants	16 Participants n=5 Participants	14 Participants n=4 Participants	16 Participants n=21 Participants	9 Participants n=10 Participants	87 Participants n=115 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	6 Participants n=21 Participants	12 Participants n=10 Participants	45 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=10 Participants	18 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	20 Participants n=4 Participants	20 Participants n=21 Participants	18 Participants n=10 Participants	114 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=10 Participants	11 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants	20 Participants n=115 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	18 Participants n=7 Participants	15 Participants n=5 Participants	18 Participants n=4 Participants	17 Participants n=21 Participants	18 Participants n=10 Participants	101 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment United States	22 Participants n=5 Participants	23 Participants n=7 Participants	22 Participants n=5 Participants	22 Participants n=4 Participants	22 Participants n=21 Participants	21 Participants n=10 Participants	132 Participants n=115 Participants

PRIMARY outcome

Timeframe: From First dose to Post-operative Day 28 (Part A) or Day 22 (Part B)

Population: Safety Population

Number of treatment emergent adverse events and number of participants.

Outcome measures

Outcome measures
Measure	APP13007 0.05% Twice Daily (BID) n=22 Participants 1 drop 0.05% APP13007 twice daily for 21 days to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) n=23 Participants 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.05% Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.1% Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1%	APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) n=21 Participants 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%
Number of Treatment Emergent Adverse Events	4 Participants	7 Participants	3 Participants	8 Participants	6 Participants	3 Participants

PRIMARY outcome

Timeframe: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)

Population: Safety Population - Participants who had the IOP data at End of Treatment

Intraocular pressure is measured in mm Hg at each study visit with a Goldmann applanation tonometer. The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit.

Outcome measures

Outcome measures
Measure	APP13007 0.05% Twice Daily (BID) n=20 Participants 1 drop 0.05% APP13007 twice daily for 21 days to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) n=16 Participants 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.05% Twice Daily (BID) and Once Daily (QD) n=19 Participants 1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) n=16 Participants 1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.1% Twice Daily (BID) and Once Daily (QD) n=20 Participants 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1%	APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) n=15 Participants 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%
Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye	1.1 mmHg Standard Deviation 4.2	-2.3 mmHg Standard Deviation 4.0	-2.37 mmHg Standard Deviation 3.71	-2.38 mmHg Standard Deviation 3.14	-1.28 mmHg Standard Deviation 4.36	-1.00 mmHg Standard Deviation 2.30

PRIMARY outcome

Timeframe: Baseline and Post-operative Day 15

Population: 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

Outcome measures
Measure	APP13007 0.05% Twice Daily (BID) n=22 Participants 1 drop 0.05% APP13007 twice daily for 21 days to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) n=23 Participants 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.05% Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.1% Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1%	APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) n=21 Participants 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%
Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye	-16.64 cells/mm^2 Standard Deviation 5.80	-9.24 cells/mm^2 Standard Deviation 10.34	-11.48 cells/mm^2 Standard Deviation 8.65	-5.67 cells/mm^2 Standard Deviation 11.73	-11.90 cells/mm^2 Standard Deviation 4.73	-7.43 cells/mm^2 Standard Deviation 11.15

PRIMARY outcome

Timeframe: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)

Population: 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 number of incorrect letters.

Outcome measures

Outcome measures
Measure	APP13007 0.05% Twice Daily (BID) n=22 Participants 1 drop 0.05% APP13007 twice daily for 21 days to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) n=23 Participants 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.05% Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.1% Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1%	APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) n=21 Participants 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%
Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye	-0.179 logMAR score Standard Deviation 0.266	-0.073 logMAR score Standard Deviation 0.174	-0.106 logMAR score Standard Deviation 0.184	-0.024 logMAR score Standard Deviation 0.133	-0.130 logMAR score Standard Deviation 0.165	-0.025 logMAR score Standard Deviation 0.192

PRIMARY outcome

Timeframe: Baseline and Post-operative Day 15

Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.

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).

Outcome measures

Outcome measures
Measure	APP13007 0.05% Twice Daily (BID) n=22 Participants 1 drop 0.05% APP13007 twice daily for 21 days to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) n=23 Participants 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.05% Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.1% Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1%	APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) n=21 Participants 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%
Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye	-0.8 grade Standard Deviation 1.0	-0.4 grade Standard Deviation 1.1	-1.1 grade Standard Deviation 1.0	-0.4 grade Standard Deviation 2.0	-0.6 grade Standard Deviation 1.2	-0.3 grade Standard Deviation 1.5

SECONDARY outcome

Timeframe: Post-operative Day 15

Population: 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

Outcome measures
Measure	APP13007 0.05% Twice Daily (BID) n=22 Participants 1 drop 0.05% APP13007 twice daily for 21 days to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) n=23 Participants 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.05% Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.1% Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1%	APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) n=21 Participants 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%
Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication	15 Participants	8 Participants	10 Participants	7 Participants	13 Participants	8 Participants

SECONDARY outcome

Timeframe: Post-operative Day 15

Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.

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).

Outcome measures

Outcome measures
Measure	APP13007 0.05% Twice Daily (BID) n=22 Participants 1 drop 0.05% APP13007 twice daily for 21 days to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) n=23 Participants 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.05% Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.1% Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1%	APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) n=21 Participants 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%
Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication	21 Participants	16 Participants	20 Participants	16 Participants	19 Participants	15 Participants

SECONDARY outcome

Timeframe: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)

Population: 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). The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit.

Outcome measures

Outcome measures
Measure	APP13007 0.05% Twice Daily (BID) n=22 Participants 1 drop 0.05% APP13007 twice daily for 21 days to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) n=23 Participants 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.05% Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05%	APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%	APP13007 0.1% Twice Daily (BID) and Once Daily (QD) n=22 Participants 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1%	APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) n=21 Participants 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%
Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye	-1.05 grade Standard Deviation 0.58	-0.39 grade Standard Deviation 0.94	-0.77 grade Standard Deviation 0.81	-0.48 grade Standard Deviation 0.96	-0.64 grade Standard Deviation 0.49	-0.10 grade Standard Deviation 1.04

SECONDARY outcome

Timeframe: First dose to Post-operative Day 22 (Part A) or Day 15 (Part B)

Population: Intent to Treat Population

Subjects who do not respond to study treatment after randomization (anterior chamber cell count \> 30 cells or an increase in anterior chamber cell count by \> 15 cells from pre-dose baseline or ≥ 2 grade of increase in anterior chamber flare from pre-dose baseline) are started on anti-inflammatory medication (referred to as 'Rescue' medication). The number of subjects starting 'Rescue' medication is recorded at each study visit.