Trial Outcomes & Findings for Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR) (NCT NCT01193127)

NCT ID: NCT01193127

Last Updated: 2014-08-28

Results Overview

Pupil diameter from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment group and time point. Repeated measures analyses of variance were used to test for differences in the maintenance of mydriasis. The repeated measures model included change from baseline pupil diameter as the response variable and treatment (OMS302, ketorolac tromethamine, and vehicle), time point (as a categorical variable) and the stratification factor lens opacities classification system II (LOCS II) grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working-correlation structure was used.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 223 participants
• Primary outcome timeframe: During surgery (immediately prior to surgical incision to wound closure)
• Results posted on: 2014-08-28

Participant Flow

Participant milestones

Measure	Balanced Salt Solution (BSS) Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution OMS302 Solution OMS302 Solution
Randomized STARTED	57	54	55	57
Randomized COMPLETED	57	54	55	56
Randomized NOT COMPLETED	0	0	0	1
Treated STARTED	57	54	55	56
Treated COMPLETED	57	54	55	55
Treated NOT COMPLETED	0	0	0	1

Reasons for withdrawal

Measure	Balanced Salt Solution (BSS) Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution OMS302 Solution OMS302 Solution
Randomized Surgery Cancelled	0	0	0	1
Treated Withdrawal by Subject	0	0	0	1

Baseline Characteristics

Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)

Baseline characteristics by cohort

Measure	Balanced Salt Solution (BSS) n=57 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=54 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=56 Participants OMS302 Solution OMS302 Solution	Total n=222 Participants Total of all reporting groups
Age, Continuous	68.5 years STANDARD_DEVIATION 9.6 • n=5 Participants	67.6 years STANDARD_DEVIATION 10.6 • n=7 Participants	66.8 years STANDARD_DEVIATION 8.6 • n=5 Participants	66.4 years STANDARD_DEVIATION 11.2 • n=4 Participants	67.3 years STANDARD_DEVIATION 10.0 • n=21 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	34 Participants n=7 Participants	33 Participants n=5 Participants	37 Participants n=4 Participants	137 Participants n=21 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	20 Participants n=7 Participants	22 Participants n=5 Participants	19 Participants n=4 Participants	85 Participants n=21 Participants

PRIMARY outcome

Timeframe: During surgery (immediately prior to surgical incision to wound closure)

Population: Subjects with interpretable video recordings obtained during surgery.

Pupil diameter from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment group and time point. Repeated measures analyses of variance were used to test for differences in the maintenance of mydriasis. The repeated measures model included change from baseline pupil diameter as the response variable and treatment (OMS302, ketorolac tromethamine, and vehicle), time point (as a categorical variable) and the stratification factor lens opacities classification system II (LOCS II) grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working-correlation structure was used.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=53 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=49 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=52 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=49 Participants OMS302 Solution OMS302 Solution
Pupil Diameter (mm) During Surgery Baseline; n = 53, 49, 52, 49	8.0 mm Standard Deviation 2.0	8.0 mm Standard Deviation 1.8	8.1 mm Standard Deviation 1.6	9.0 mm Standard Deviation 2.9
Pupil Diameter (mm) During Surgery 1 minute; n = 53, 48, 52, 48	8.2 mm Standard Deviation 2.1	8.3 mm Standard Deviation 1.9	8.3 mm Standard Deviation 1.6	9.4 mm Standard Deviation 3.1
Pupil Diameter (mm) During Surgery 3 minutes; n = 53, 49, 52, 49	7.9 mm Standard Deviation 2.2	8.4 mm Standard Deviation 1.8	8.1 mm Standard Deviation 1.7	9.2 mm Standard Deviation 3.1
Pupil Diameter (mm) During Surgery 4 minutes; n = 52, 49, 52, 49	7.6 mm Standard Deviation 2.0	8.4 mm Standard Deviation 1.8	7.9 mm Standard Deviation 1.8	9.4 mm Standard Deviation 3.1
Pupil Diameter (mm) During Surgery 5 minutes; n = 52, 49, 51, 48	7.5 mm Standard Deviation 2.3	8.2 mm Standard Deviation 1.9	7.9 mm Standard Deviation 1.9	9.1 mm Standard Deviation 2.8
Pupil Diameter (mm) During Surgery 6 minutes; n = 51, 45, 50, 48	7.4 mm Standard Deviation 2.6	8.1 mm Standard Deviation 2.0	7.7 mm Standard Deviation 1.8	9.1 mm Standard Deviation 3.1
Pupil Diameter (mm) During Surgery 7 minutes; n = 45, 37, 44, 43	7.1 mm Standard Deviation 2.7	8.0 mm Standard Deviation 2.3	7.2 mm Standard Deviation 2.0	9.0 mm Standard Deviation 3.1
Pupil Diameter (mm) During Surgery 9 minutes; n = 27, 25, 32, 32	7.3 mm Standard Deviation 3.0	8.1 mm Standard Deviation 2.6	7.0 mm Standard Deviation 1.9	8.9 mm Standard Deviation 3.0
Pupil Diameter (mm) During Surgery 10 minutes; n = 26, 19, 25, 28	7.1 mm Standard Deviation 2.5	8.3 mm Standard Deviation 2.8	7.0 mm Standard Deviation 1.5	8.8 mm Standard Deviation 3.2
Pupil Diameter (mm) During Surgery 11 minutes; n = 24, 18, 22, 27	7.0 mm Standard Deviation 2.9	8.3 mm Standard Deviation 2.7	7.1 mm Standard Deviation 1.4	8.8 mm Standard Deviation 3.2
Pupil Diameter (mm) During Surgery 12 minutes; n = 22, 17, 20, 23	6.9 mm Standard Deviation 3.0	8.0 mm Standard Deviation 2.7	7.0 mm Standard Deviation 1.1	9.2 mm Standard Deviation 3.8
Pupil Diameter (mm) During Surgery 13 minutes; n = 14, 13, 16, 17	6.2 mm Standard Deviation 1.6	8.0 mm Standard Deviation 2.9	6.8 mm Standard Deviation 1.4	8.7 mm Standard Deviation 3.3
Pupil Diameter (mm) During Surgery 14 minutes; n = 10, 8, 13, 10	6.3 mm Standard Deviation 1.8	7.7 mm Standard Deviation 2.8	6.5 mm Standard Deviation 1.4	9.5 mm Standard Deviation 3.0
Pupil Diameter (mm) During Surgery 15 minutes; n = 8, 7, 8, 9	6.1 mm Standard Deviation 1.6	7.9 mm Standard Deviation 2.7	6.9 mm Standard Deviation 2.1	9.9 mm Standard Deviation 3.7
Pupil Diameter (mm) During Surgery 16 minutes; n = 7, 6, 7, 6	5.8 mm Standard Deviation 1.9	8.4 mm Standard Deviation 3.0	6.7 mm Standard Deviation 1.6	10.4 mm Standard Deviation 4.8
Pupil Diameter (mm) During Surgery 17 minutes; n = 7, 5, 6, 5	5.6 mm Standard Deviation 1.8	7.2 mm Standard Deviation 1.4	6.8 mm Standard Deviation 1.7	12.0 mm Standard Deviation 5.1
Pupil Diameter (mm) During Surgery 18 minutes; n = 6, 3, 5, 5	5.4 mm Standard Deviation 1.6	7.9 mm Standard Deviation 0.9	6.8 mm Standard Deviation 3.1	12.0 mm Standard Deviation 5.6
Pupil Diameter (mm) During Surgery 19 minutes; n = 3, 3, 4, 5	5.2 mm Standard Deviation 2.1	7.8 mm Standard Deviation 1.0	6.7 mm Standard Deviation 3.9	11.5 mm Standard Deviation 5.0
Pupil Diameter (mm) During Surgery 20 minutes; n = 2, 2, 2, 3	5.2 mm Standard Deviation 3.2	8.1 mm Standard Deviation 1.4	5.2 mm Standard Deviation 0.9	12.4 mm Standard Deviation 6.3
Pupil Diameter (mm) During Surgery 21 minutes; n = 2, 2, 0, 3	4.9 mm Standard Deviation 3.3	8.0 mm Standard Deviation 1.5	NA mm Standard Deviation NA No subjects in this treatment group continuing surgery past this time point.	12.0 mm Standard Deviation 5.8
Pupil Diameter (mm) During Surgery 22 minutes; n = 1, 2, 0, 2	2.3 mm Standard Deviation 0	7.5 mm Standard Deviation 1.5	NA mm Standard Deviation NA No subjects in this treatment group continuing surgery past this time point.	14.6 mm Standard Deviation 7.6
Pupil Diameter (mm) During Surgery 23 minutes; n = 1, 1, 0, 2	3.0 mm Standard Deviation 0	6.6 mm Standard Deviation 0	NA mm Standard Deviation NA No subjects in this treatment group continuing surgery past this time point.	14.6 mm Standard Deviation 7.1
Pupil Diameter (mm) During Surgery 25 minutes; n = 1, 1, 0, 2	2.6 mm Standard Deviation 0	6.4 mm Standard Deviation 0	NA mm Standard Deviation NA No subjects in this treatment group continuing surgery past this time point.	13.9 mm Standard Deviation 5.9
Pupil Diameter (mm) During Surgery 26 minutes; n = 1, 0, 0, 1	3.1 mm Standard Deviation 0	NA mm Standard Deviation NA No subjects in this treatment group continuing surgery past this time point.	NA mm Standard Deviation NA No subjects in this treatment group continuing surgery past this time point.	17.2 mm Standard Deviation 0
Pupil Diameter (mm) During Surgery 2 minutes; n = 53, 49, 52, 49	8.0 mm Standard Deviation 2.0	8.3 mm Standard Deviation 1.7	8.2 mm Standard Deviation 1.8	9.2 mm Standard Deviation 3.2
Pupil Diameter (mm) During Surgery 8 minutes; n = 34, 28, 40, 36	7.1 mm Standard Deviation 2.7	7.8 mm Standard Deviation 2.5	7.1 mm Standard Deviation 2.1	8.7 mm Standard Deviation 3.0
Pupil Diameter (mm) During Surgery 24 minutes; n = 1, 1, 0, 2	4.2 mm Standard Deviation 0	7.1 mm Standard Deviation 0	NA mm Standard Deviation NA No subjects in this treatment group continuing surgery past this time point.	13.0 mm Standard Deviation 5.7
Pupil Diameter (mm) During Surgery 27 minutes; n = 1, 0, 0, 1	3.3 mm Standard Deviation 0	NA mm Standard Deviation NA No subjects in this treatment group continuing surgery past this time point.	NA mm Standard Deviation NA No subjects in this treatment group continuing surgery past this time point.	17.4 mm Standard Deviation 0
Pupil Diameter (mm) During Surgery 28 minutes; n = 1, 0, 0, 1	3.6 mm Standard Deviation 0	NA mm Standard Deviation NA No subjects in this treatment group continuing surgery past this time point.	NA mm Standard Deviation NA No subjects in this treatment group continuing surgery past this time point.	17.1 mm Standard Deviation 0
Pupil Diameter (mm) During Surgery 29 minutes; n = 1, 0, 0, 1	3.4 mm Standard Deviation 0	NA mm Standard Deviation NA No subjects in this treatment group continuing surgery past this time point.	NA mm Standard Deviation NA No subjects in this treatment group continuing surgery past this time point.	18.7 mm Standard Deviation 0
Pupil Diameter (mm) During Surgery 30 minutes; n = 1, 0, 0, 0	4.1 mm Standard Deviation 0	NA mm Standard Deviation NA No subjects in this treatment group continuing surgery past this time point.	NA mm Standard Deviation NA No subjects in this treatment group continuing surgery past this time point.	NA mm Standard Deviation NA No subjects in this treatment group continuing surgery past this time point.
Pupil Diameter (mm) During Surgery 31 minutes; n = 1, 0, 0, 0	3.2 mm Standard Deviation 0	NA mm Standard Deviation NA No subjects in this treatment group continuing surgery past this time point.	NA mm Standard Deviation NA No subjects in this treatment group continuing surgery past this time point.	NA mm Standard Deviation NA No subjects in this treatment group continuing surgery past this time point.

PRIMARY outcome

Timeframe: through 12 hours post-surgery

Population: Subjects with postoperative VAS scores.

For the primary analysis of this endpoint, only the results on the day of operation at 2, 4, 6, 8 and 10-12 hours were utilized. The VAS scores (where 0 = no pain and 100 = worst possible pain) were summarized by treatment group and time point. Repeated measures analyses of variance were used to test for differences in postoperative ocular pain. The repeated measures model included VAS pain score as the response variable and treatment (OMS302, phenylephrine hydrochloride (PE), and vehicle), time point (as a categorical variable) and the stratification factor LOCS II grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working correlation structure was used.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively 6 hours post-surgery	10.5 units on a scale Standard Deviation 17.2	9.5 units on a scale Standard Deviation 14.9	4.3 units on a scale Standard Deviation 10.9	3.9 units on a scale Standard Deviation 8.6
Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively 8 hours post-surgery	8.9 units on a scale Standard Deviation 14.7	12.2 units on a scale Standard Deviation 16.9	4.0 units on a scale Standard Deviation 11.0	4.0 units on a scale Standard Deviation 10.5
Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively 2 hours post-surgery	8.6 units on a scale Standard Deviation 14.7	9.4 units on a scale Standard Deviation 16.8	4.1 units on a scale Standard Deviation 12.7	5.3 units on a scale Standard Deviation 11.8
Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively 4 hours post-surgery	10.9 units on a scale Standard Deviation 19.3	10.5 units on a scale Standard Deviation 16.9	4.8 units on a scale Standard Deviation 12.3	5.9 units on a scale Standard Deviation 12.4
Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively 10-12 hours post-surgery	10.3 units on a scale Standard Deviation 18.3	11.8 units on a scale Standard Deviation 17.1	3.4 units on a scale Standard Deviation 9.2	4.7 units on a scale Standard Deviation 13.4

SECONDARY outcome

Timeframe: Two hours

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=54 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery None	41 participants	34 participants	48 participants	35 participants
Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery Mild	12 participants	13 participants	6 participants	14 participants
Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery Moderate	3 participants	7 participants	0 participants	4 participants
Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery Severe	0 participants	2 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: Six hours

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=54 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=53 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=50 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=50 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery Mild	12 participants	15 participants	6 participants	13 participants
Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery Moderate	7 participants	6 participants	1 participants	1 participants
Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery None	34 participants	29 participants	43 participants	35 participants
Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery Severe	1 participants	3 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: One day

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=54 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery Mild	15 participants	19 participants	6 participants	10 participants
Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery Moderate	5 participants	4 participants	1 participants	1 participants
Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery None	34 participants	29 participants	48 participants	42 participants
Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery Severe	2 participants	3 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Two days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery Mild	18 participants	18 participants	7 participants	12 participants
Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery Moderate	1 participants	6 participants	0 participants	1 participants
Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery None	37 participants	30 participants	47 participants	41 participants
Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery Severe	0 participants	1 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: Seven days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=53 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=53 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery None	39 participants	33 participants	46 participants	40 participants
Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery Mild	13 participants	21 participants	5 participants	13 participants
Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery Moderate	1 participants	1 participants	2 participants	1 participants
Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery Severe	0 participants	1 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: 14 days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=55 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=54 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=53 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery None	44 participants	45 participants	51 participants	42 participants
Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery Mild	7 participants	10 participants	3 participants	11 participants
Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery Moderate	4 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: up to 30 days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=55 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=54 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=54 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=53 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination None	43 participants	44 participants	51 participants	49 participants
Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination Mild	11 participants	9 participants	3 participants	3 participants
Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination Moderate	1 participants	1 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Two hours

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=54 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery Severe	2 participants	4 participants	0 participants	2 participants
Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery None	37 participants	27 participants	36 participants	32 participants
Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery Mild	13 participants	22 participants	13 participants	16 participants
Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery Moderate	4 participants	3 participants	6 participants	4 participants

SECONDARY outcome

Timeframe: Six hours

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=53 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=53 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=49 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=50 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery None	26 participants	29 participants	33 participants	29 participants
Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery Mild	17 participants	16 participants	12 participants	18 participants
Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery Moderate	7 participants	7 participants	4 participants	1 participants
Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery Severe	3 participants	1 participants	0 participants	2 participants

SECONDARY outcome

Timeframe: One day

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=54 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery None	20 participants	16 participants	36 participants	23 participants
Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery Mild	19 participants	22 participants	16 participants	20 participants
Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery Moderate	13 participants	11 participants	2 participants	9 participants
Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery Severe	4 participants	6 participants	1 participants	2 participants

SECONDARY outcome

Timeframe: Two days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery None	26 participants	23 participants	34 participants	19 participants
Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery Mild	18 participants	24 participants	13 participants	23 participants
Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery Moderate	12 participants	4 participants	5 participants	9 participants
Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery Severe	0 participants	4 participants	3 participants	4 participants

SECONDARY outcome

Timeframe: Seven days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=53 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=53 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery None	30 participants	31 participants	37 participants	37 participants
Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery Mild	18 participants	16 participants	11 participants	12 participants
Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery Moderate	4 participants	8 participants	3 participants	1 participants
Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery Severe	1 participants	1 participants	2 participants	5 participants

SECONDARY outcome

Timeframe: 14 days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=55 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=54 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=53 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery None	43 participants	35 participants	42 participants	39 participants
Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery Mild	10 participants	18 participants	9 participants	12 participants
Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery Moderate	2 participants	2 participants	3 participants	1 participants
Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery Severe	0 participants	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Up to 30 days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=55 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=54 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=54 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=53 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination None	44 participants	36 participants	42 participants	40 participants
Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination Mild	10 participants	17 participants	12 participants	10 participants
Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination Moderate	1 participants	1 participants	0 participants	2 participants
Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination Severe	0 participants	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Two hours

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=54 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery None	55 participants	50 participants	52 participants	48 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery Mild	1 participants	6 participants	2 participants	4 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery Moderate	0 participants	0 participants	0 participants	2 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery Severe	0 participants	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Six hours

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=54 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=53 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=50 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=50 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery Moderate	3 participants	3 participants	1 participants	2 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery None	44 participants	49 participants	41 participants	43 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery Mild	7 participants	1 participants	8 participants	5 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery Severe	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: One day

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=54 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery Severe	1 participants	0 participants	0 participants	0 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery None	48 participants	45 participants	48 participants	50 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery Mild	7 participants	9 participants	6 participants	4 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery Moderate	0 participants	1 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Two days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery Mild	3 participants	7 participants	8 participants	5 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery None	52 participants	48 participants	46 participants	49 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery Moderate	1 participants	0 participants	0 participants	1 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery Severe	0 participants	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Seven days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=53 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=53 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery Mild	4 participants	4 participants	1 participants	1 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery Moderate	0 participants	0 participants	0 participants	2 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery Severe	0 participants	0 participants	0 participants	0 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery None	49 participants	52 participants	52 participants	52 participants

SECONDARY outcome

Timeframe: 14 days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=55 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=54 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=53 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery Mild	3 participants	4 participants	1 participants	4 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery Moderate	0 participants	0 participants	0 participants	0 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery Severe	0 participants	0 participants	0 participants	0 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery None	52 participants	51 participants	53 participants	49 participants

SECONDARY outcome

Timeframe: Up to 30 days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=55 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=54 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=54 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=53 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination None	52 participants	52 participants	53 participants	50 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination Mild	3 participants	2 participants	1 participants	3 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination Moderate	0 participants	0 participants	0 participants	0 participants
Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination Severe	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Two hours

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=54 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery None	49 participants	48 participants	45 participants	47 participants
Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery Mild	5 participants	7 participants	9 participants	6 participants
Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery Moderate	1 participants	1 participants	1 participants	1 participants
Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery Severe	1 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Six hours

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=54 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=53 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=49 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=50 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery None	44 participants	43 participants	39 participants	43 participants
Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery Mild	7 participants	9 participants	10 participants	6 participants
Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery Moderate	3 participants	1 participants	0 participants	1 participants
Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery Severe	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: One day

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=54 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery None	45 participants	49 participants	49 participants	46 participants
Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery Mild	10 participants	6 participants	6 participants	6 participants
Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery Moderate	1 participants	0 participants	0 participants	2 participants
Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery Severe	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Two days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery None	45 participants	44 participants	46 participants	41 participants
Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery Mild	11 participants	10 participants	9 participants	14 participants
Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery Moderate	0 participants	1 participants	0 participants	0 participants
Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery Severe	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Seven days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=53 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=53 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery Severe	0 participants	0 participants	0 participants	0 participants
Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery None	39 participants	47 participants	40 participants	42 participants
Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery Mild	13 participants	9 participants	13 participants	12 participants
Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery Moderate	1 participants	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: 14 days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=55 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=54 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=53 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery None	48 participants	45 participants	44 participants	44 participants
Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery Mild	6 participants	10 participants	10 participants	8 participants
Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery Moderate	1 participants	0 participants	0 participants	1 participants
Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery Severe	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Up to 30 days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=55 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=54 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=54 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=53 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination None	43 participants	46 participants	47 participants	48 participants
Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination Moderate	1 participants	0 participants	0 participants	0 participants
Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination Severe	0 participants	0 participants	0 participants	0 participants
Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination Mild	11 participants	8 participants	7 participants	5 participants

SECONDARY outcome

Timeframe: Two hours

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=54 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery Mild	17 participants	24 participants	20 participants	19 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery Moderate	6 participants	4 participants	3 participants	9 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery None	32 participants	26 participants	31 participants	25 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery Severe	1 participants	2 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: Six hours

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=54 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=53 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=49 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=50 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery Severe	1 participants	2 participants	0 participants	1 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery None	26 participants	31 participants	31 participants	34 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery Mild	19 participants	16 participants	16 participants	10 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery Moderate	8 participants	4 participants	2 participants	5 participants

SECONDARY outcome

Timeframe: One day

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=54 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery Mild	13 participants	25 participants	16 participants	16 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery Severe	0 participants	0 participants	0 participants	1 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery None	36 participants	25 participants	37 participants	35 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery Moderate	7 participants	5 participants	2 participants	2 participants

SECONDARY outcome

Timeframe: Two days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery None	37 participants	39 participants	38 participants	35 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery Mild	16 participants	11 participants	15 participants	15 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery Moderate	3 participants	3 participants	1 participants	5 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery Severe	0 participants	2 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Seven days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=53 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=53 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days None	27 participants	32 participants	34 participants	37 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days Moderate	3 participants	5 participants	2 participants	2 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days Mild	23 participants	17 participants	17 participants	15 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days Severe	0 participants	2 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: 14 days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=55 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=54 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=53 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery None	31 participants	38 participants	36 participants	42 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery Mild	23 participants	16 participants	16 participants	9 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery Moderate	1 participants	1 participants	1 participants	2 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery Severe	0 participants	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Up to 30 days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=55 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=54 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=54 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=53 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination Moderate	2 participants	0 participants	0 participants	1 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination None	41 participants	44 participants	40 participants	46 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination Mild	12 participants	10 participants	14 participants	6 participants
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination Severe	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Two hours

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=54 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery Severe	2 participants	3 participants	1 participants	2 participants
Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery None	27 participants	24 participants	28 participants	17 participants
Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery Mild	21 participants	17 participants	18 participants	25 participants
Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery Moderate	6 participants	12 participants	8 participants	10 participants

SECONDARY outcome

Timeframe: Six hours

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=53 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=53 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=49 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=50 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery None	24 participants	20 participants	26 participants	23 participants
Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery Mild	21 participants	20 participants	13 participants	19 participants
Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery Moderate	7 participants	10 participants	10 participants	8 participants
Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery Severe	1 participants	3 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: One day

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=54 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery None	34 participants	29 participants	36 participants	38 participants
Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery Mild	15 participants	19 participants	17 participants	12 participants
Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery Moderate	7 participants	4 participants	2 participants	3 participants
Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery Severe	0 participants	3 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Two days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery Mild	19 participants	17 participants	13 participants	8 participants
Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery None	36 participants	31 participants	39 participants	43 participants
Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery Moderate	1 participants	5 participants	3 participants	4 participants
Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery Severe	0 participants	2 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Seven days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=53 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=53 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery None	36 participants	33 participants	34 participants	41 participants
Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery Mild	16 participants	17 participants	18 participants	11 participants
Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery Moderate	1 participants	6 participants	1 participants	2 participants
Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery Severe	0 participants	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: 14 days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=55 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=54 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=53 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery Mild	10 participants	16 participants	13 participants	4 participants
Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery Moderate	6 participants	5 participants	1 participants	2 participants
Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery None	39 participants	34 participants	39 participants	47 participants
Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery Severe	0 participants	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Up to 30 days

Population: Subjects with scores at time point.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=55 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=54 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=54 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=53 Participants OMS302 Solution OMS302 Solution
Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination Mild	14 participants	6 participants	10 participants	7 participants
Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination Moderate	3 participants	6 participants	0 participants	2 participants
Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination None	38 participants	42 participants	44 participants	44 participants
Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination Severe	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline

Population: Subjects with scores at time point.

Best-Corrected Visual Acuity (BCVA) was summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=54 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=53 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=56 Participants OMS302 Solution OMS302 Solution
Best Corrected Visual Acuity (BVCA) - Log Score, Baseline	0.4 Log score Standard Deviation 0.3	0.4 Log score Standard Deviation 0.2	0.4 Log score Standard Deviation 0.2	0.4 Log score Standard Deviation 0.3

SECONDARY outcome

Timeframe: One day

Population: Subjects with scores at time point.

Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=54 Participants OMS302 Solution OMS302 Solution
Best Corrected Visual Acuity (BVCA) - Log Score, Day 1	0.1 Log score Standard Deviation 0.2	0.2 Log score Standard Deviation 0.3	0.2 Log score Standard Deviation 0.2	0.1 Log score Standard Deviation 0.2

SECONDARY outcome

Timeframe: Two days

Population: Subjects with scores at time point.

Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Best Corrected Visual Acuity (BVCA) - Log Score, Day 2	0.1 Log score Standard Deviation 0.2	0.2 Log score Standard Deviation 0.3	0.1 Log score Standard Deviation 0.2	0.1 Log score Standard Deviation 0.1

SECONDARY outcome

Timeframe: Seven days

Population: Subjects with scores at time point.

Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=53 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Best Corrected Visual Acuity (BVCA) - Log Score, Day 7	0.1 Log score Standard Deviation 0.2	0.1 Log score Standard Deviation 0.2	0.1 Log score Standard Deviation 0.1	0.1 Log score Standard Deviation 0.2

SECONDARY outcome

Timeframe: 14 days

Population: Subjects with scores at time point.

Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=55 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=53 Participants OMS302 Solution OMS302 Solution
Best Corrected Visual Acuity (BVCA) - Log Score, Day 14	0.1 Log score Standard Deviation 0.2	0.1 Log score Standard Deviation 0.2	0.1 Log score Standard Deviation 0.2	0.1 Log score Standard Deviation 0.1

SECONDARY outcome

Timeframe: 30 days

Population: Subjects with scores at time point.

Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=54 Participants OMS302 Solution OMS302 Solution
Best Corrected Visual Acuity (BVCA) - Log Score, Day 30	0.1 Log score Standard Deviation 0.2	0.1 Log score Standard Deviation 0.2	0.1 Log score Standard Deviation 0.2	0.1 Log score Standard Deviation 0.1

SECONDARY outcome

Timeframe: Baseline

Population: Subjects with scores at time point.

Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

Grading was as follows:

Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Baseline	0.0 units on a scale Standard Deviation 0.0	0.0 units on a scale Standard Deviation 0.0	0.0 units on a scale Standard Deviation 0.1	0.0 units on a scale Standard Deviation 0.1

SECONDARY outcome

Timeframe: Two hours

Population: Subjects with scores at time point.

TPostoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

Grading was as follows:

Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, 2 Hours Post Surgery	2.7 units on a scale Standard Deviation 1.4	2.2 units on a scale Standard Deviation 1.3	2.5 units on a scale Standard Deviation 1.3	2.5 units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: One day

Population: Subjects with scores at time point.

Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

Grading was as follows:

Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 1	2.7 units on a scale Standard Deviation 1.4	2.3 units on a scale Standard Deviation 1.3	2.6 units on a scale Standard Deviation 1.3	2.2 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Two days

Population: Subjects with scores at time point.

Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

Grading was as follows:

Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 2	2.4 units on a scale Standard Deviation 1.3	2.0 units on a scale Standard Deviation 1.2	2.6 units on a scale Standard Deviation 1.4	2.2 units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Seven days

Population: Subjects with scores at time point.

Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

Grading was as follows:

Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=53 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 7	1.5 units on a scale Standard Deviation 1.2	1.4 units on a scale Standard Deviation 1.2	1.5 units on a scale Standard Deviation 1.3	1.9 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 14 days

Population: Subjects with scores at time point.

Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

Grading was as follows:

Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

Outcome measures

Measure	Balanced Salt Solution (BSS) n=55 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=53 Participants OMS302 Solution OMS302 Solution
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 14	0.7 units on a scale Standard Deviation 0.7	0.6 units on a scale Standard Deviation 0.8	0.7 units on a scale Standard Deviation 0.9	0.8 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 30 days

Population: Subjects with scores at time point.

Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

Grading was as follows:

Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=54 Participants OMS302 Solution OMS302 Solution
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 30	0.4 units on a scale Standard Deviation 0.7	0.2 units on a scale Standard Deviation 0.5	0.3 units on a scale Standard Deviation 0.6	0.2 units on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: Baseline

Population: Subjects with scores at time point.

Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

Grading was as follows:

Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Subjects With Postoperative Ocular Inflammation SOIS = 0, Baseline	56 participants	56 participants	54 participants	54 participants

SECONDARY outcome

Timeframe: Two hours

Population: Subjects with scores at time point.

Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

Grading was as follows:

Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Subjects With Postoperative Ocular Inflammation SOIS = 0, Two Hours Post-surgery	1 participants	3 participants	1 participants	2 participants

SECONDARY outcome

Timeframe: One day

Population: Subjects with scores at time point.

Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

Grading was as follows:

Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 1	1 participants	1 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Two days

Population: Subjects with scores at time point.

Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

Grading was as follows:

Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 2	1 participants	2 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: Seven days

Population: Subjects with scores at time point.

Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

Grading was as follows:

Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=53 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 7	9 participants	11 participants	12 participants	8 participants

SECONDARY outcome

Timeframe: 14 days

Population: Subjects with scores at time point.

Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

Grading was as follows:

Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

Outcome measures

Measure	Balanced Salt Solution (BSS) n=55 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=53 Participants OMS302 Solution OMS302 Solution
Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 14	25 participants	29 participants	28 participants	25 participants

SECONDARY outcome

Timeframe: 30 days

Population: Subjects with scores at time point.

Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

Grading was as follows:

Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=54 Participants OMS302 Solution OMS302 Solution
Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 30	40 participants	43 participants	42 participants	40 participants

SECONDARY outcome

Timeframe: Two hours

Population: Subjects with data at time point.

The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=54 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=52 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=53 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=53 Participants OMS302 Solution OMS302 Solution
Postoperative Mean Anterior Chamber Cell Count, Two Hours Post-Surgery	11.2 cells Standard Deviation 9.4	9.2 cells Standard Deviation 11.1	10.9 cells Standard Deviation 10.1	10.3 cells Standard Deviation 8.6

SECONDARY outcome

Timeframe: One day

Population: Subjects with data at time point.

The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=53 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=54 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=53 Participants OMS302 Solution OMS302 Solution
Postoperative Mean Anterior Chamber Cell Count, Day 1	11.2 cells Standard Deviation 9.5	9.3 cells Standard Deviation 9.7	10.4 cells Standard Deviation 8.9	8.4 cells Standard Deviation 6.7

SECONDARY outcome

Timeframe: Two days

Population: Subjects with data at time point.

The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=54 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=54 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=53 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=54 Participants OMS302 Solution OMS302 Solution
Postoperative Mean Anterior Chamber Cell Count, Day 2	9.1 cells Standard Deviation 6.4	6.8 cells Standard Deviation 7.8	10.2 cells Standard Deviation 7.6	7.2 cells Standard Deviation 6.0

SECONDARY outcome

Timeframe: Seven days

Population: Subjects with data at time point.

The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=55 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=52 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=54 Participants OMS302 Solution OMS302 Solution
Postoperative Mean Anterior Chamber Cell Count, Day 7	4.5 cells Standard Deviation 5.2	4.2 cells Standard Deviation 7.5	3.6 cells Standard Deviation 4.6	6.9 cells Standard Deviation 10.1

SECONDARY outcome

Timeframe: 14 days

Population: Subjects with data at time point.

The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=54 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=54 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=52 Participants OMS302 Solution OMS302 Solution
Postoperative Mean Anterior Chamber Cell Count, Day 14	1.6 cells Standard Deviation 2.1	1.3 cells Standard Deviation 2.4	1.6 cells Standard Deviation 2.7	2.1 cells Standard Deviation 3.9

SECONDARY outcome

Timeframe: 30 days

Population: Subjects with data at time point.

The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=55 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=55 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=53 Participants OMS302 Solution OMS302 Solution
Postoperative Mean Anterior Chamber Cell Count, Day 30	1.1 cells Standard Deviation 2.3	0.3 cells Standard Deviation 0.8	0.5 cells Standard Deviation 1.2	0.5 cells Standard Deviation 1.2

SECONDARY outcome

Timeframe: 43 days

Population: Subjects with data at time point.

VAS pain scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery were summarized.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=55 Participants OMS302 Solution OMS302 Solution
Ocular Pain VAS Score After Day 0 Day 1 AM; n = 55, 54, 55, 55	13.4 mm Standard Deviation 21.7	13.0 mm Standard Deviation 18.1	2.7 mm Standard Deviation 8.3	7.7 mm Standard Deviation 18.4
Ocular Pain VAS Score After Day 0 Day 2 AM; n = 55, 55, 55, 54	7.7 mm Standard Deviation 11.1	10.8 mm Standard Deviation 18.2	9.5 mm Standard Deviation 18.9	10.9 mm Standard Deviation 13.7
Ocular Pain VAS Score After Day 0 Day 2 PM; n = 52, 55, 53, 53	5.3 mm Standard Deviation 9.4	7.3 mm Standard Deviation 15.5	7.2 mm Standard Deviation 15.4	6.4 mm Standard Deviation 11.8
Ocular Pain VAS Score After Day 0 Day 3 AM; n = 53, 53, 53, 49	4.1 mm Standard Deviation 7.0	5.4 mm Standard Deviation 11.5	4.8 mm Standard Deviation 11.3	8.9 mm Standard Deviation 18.8
Ocular Pain VAS Score After Day 0 Day 4 AM; n = 52, 53, 52, 48	2.8 mm Standard Deviation 6.0	3.5 mm Standard Deviation 8.3	3.9 mm Standard Deviation 10.8	5.0 mm Standard Deviation 10.5
Ocular Pain VAS Score After Day 0 Day 4 PM; n = 53, 52, 55, 52	4.5 mm Standard Deviation 9.2	3.7 mm Standard Deviation 9.4	4.8 mm Standard Deviation 14.2	4.1 mm Standard Deviation 8.3
Ocular Pain VAS Score After Day 0 Day 5 PM; n = 54, 55, 54, 51	3.9 mm Standard Deviation 8.5	3.9 mm Standard Deviation 10.4	3.3 mm Standard Deviation 9.6	5.2 mm Standard Deviation 12.5
Ocular Pain VAS Score After Day 0 Day 6 AM; n = 53, 54, 53, 50	3.5 mm Standard Deviation 6.3	4.6 mm Standard Deviation 13.3	3.6 mm Standard Deviation 10.2	6.0 mm Standard Deviation 14.3
Ocular Pain VAS Score After Day 0 Day 17; n = 2, 0, 0, 1	4.5 mm Standard Deviation 6.4	NA mm Standard Deviation NA Subjects not available for assessment at time point	NA mm Standard Deviation NA Subjects not available for assessment at time point	0.0 mm Standard Deviation 0
Ocular Pain VAS Score After Day 0 Day 22; n = 0, 1, 1, 0	NA mm Standard Deviation NA Subjects not available for assessment at time point	0.0 mm Standard Deviation 0	0.0 mm Standard Deviation 0	NA mm Standard Deviation NA Subjects not available for assessment at time point
Ocular Pain VAS Score After Day 0 Day 26; n = 0, 1, 0, 0	NA mm Standard Deviation NA Subjects not available for assessment at time point	0.0 mm Standard Deviation 0	NA mm Standard Deviation NA Subjects not available for assessment at time point	NA mm Standard Deviation NA Subjects not available for assessment at time point
Ocular Pain VAS Score After Day 0 Day 37; n = 0, 1, 0, 0	NA mm Standard Deviation NA Subjects not available for assessment at time point	0.0 mm Standard Deviation 0	NA mm Standard Deviation NA Subjects not available for assessment at time point	NA mm Standard Deviation NA Subjects not available for assessment at time point
Ocular Pain VAS Score After Day 0 Day 43; n = 0, 1, 0, 0	NA mm Standard Deviation NA Subjects not available for assessment at time point	0.0 mm Standard Deviation 0	NA mm Standard Deviation NA Subjects not available for assessment at time point	NA mm Standard Deviation NA Subjects not available for assessment at time point
Ocular Pain VAS Score After Day 0 Day 1 PM; n = 54, 54, 51, 51	6.6 mm Standard Deviation 10.2	12.6 mm Standard Deviation 19.4	6.8 mm Standard Deviation 15.1	11.6 mm Standard Deviation 20.6
Ocular Pain VAS Score After Day 0 Day 3 PM; n = 53, 55, 55, 50	4.7 mm Standard Deviation 9.8	5.1 mm Standard Deviation 11.0	3.7 mm Standard Deviation 8.7	4.4 mm Standard Deviation 10.7
Ocular Pain VAS Score After Day 0 Day 5 AM; n = 54, 54, 53, 50	3.6 mm Standard Deviation 9.9	6.4 mm Standard Deviation 18.5	3.4 mm Standard Deviation 10.6	6.5 mm Standard Deviation 14.8
Ocular Pain VAS Score After Day 0 Day 6 PM; n = 54, 53, 54, 50	2.9 mm Standard Deviation 5.5	4.0 mm Standard Deviation 11.0	2.7 mm Standard Deviation 9.3	4.6 mm Standard Deviation 12.2
Ocular Pain VAS Score After Day 0 Day 7; n = 54, 54, 54, 53	2.1 mm Standard Deviation 5.3	3.5 mm Standard Deviation 9.0	3.3 mm Standard Deviation 11.0	4.5 mm Standard Deviation 13.9
Ocular Pain VAS Score After Day 0 Day 8; n = 22, 28, 21, 13	1.3 mm Standard Deviation 2.3	4.9 mm Standard Deviation 14.7	0.6 mm Standard Deviation 1.0	2.2 mm Standard Deviation 6.3
Ocular Pain VAS Score After Day 0 Day 9; n = 4, 4, 3, 2	0.0 mm Standard Deviation 0.0	0.3 mm Standard Deviation 0.5	0.0 mm Standard Deviation 0.0	0.0 mm Standard Deviation 0.0
Ocular Pain VAS Score After Day 0 Day 10; 1, 2, 3, 1	0.0 mm Standard Deviation 0	0.5 mm Standard Deviation 0.7	0.0 mm Standard Deviation 0.0	0.0 mm Standard Deviation 0
Ocular Pain VAS Score After Day 0 Day 11; n = 1, 2, 4, 1	0.0 mm Standard Deviation 0	0.5 mm Standard Deviation 0.7	0.0 mm Standard Deviation 0.0	0.0 mm Standard Deviation 0
Ocular Pain VAS Score After Day 0 Day 12; n = 2, 2, 2, 1	2.5 mm Standard Deviation 3.5	0.5 mm Standard Deviation 0.7	0.0 mm Standard Deviation 0.0	0.0 mm Standard Deviation 0
Ocular Pain VAS Score After Day 0 Day 13; n = 11, 8, 15, 9	1.1 mm Standard Deviation 3.3	0.3 mm Standard Deviation 0.5	0.7 mm Standard Deviation 1.8	0.0 mm Standard Deviation 0.0
Ocular Pain VAS Score After Day 0 Day 14; n = 17, 16, 21, 26	2.7 mm Standard Deviation 7.7	0.2 mm Standard Deviation 0.5	1.0 mm Standard Deviation 2.2	0.6 mm Standard Deviation 1.4
Ocular Pain VAS Score After Day 0 Day 15; 22, 25, 18, 14	2.1 mm Standard Deviation 3.6	1.8 mm Standard Deviation 8.0	0.2 mm Standard Deviation 0.4	4.5 mm Standard Deviation 13.4
Ocular Pain VAS Score After Day 0 Day 16; 1, 7, 2, 5	0.0 mm Standard Deviation 0	0.0 mm Standard Deviation 0.0	0.0 mm Standard Deviation 0.0	0.0 mm Standard Deviation 0.0
Ocular Pain VAS Score After Day 0 Day 18; n = 0, 0, 1, 0	NA mm Standard Deviation NA Subjects not available for assessment at time point	NA mm Standard Deviation NA Subjects not available for assessment at time point	0.0 mm Standard Deviation 0	NA mm Standard Deviation NA Subjects not available for assessment at time point
Ocular Pain VAS Score After Day 0 Day 19; n = 1, 0, 0, 0	0.0 mm Standard Deviation 0	NA mm Standard Deviation NA Subjects not available for assessment at time point	NA mm Standard Deviation NA Subjects not available for assessment at time point	NA mm Standard Deviation NA Subjects not available for assessment at time point
Ocular Pain VAS Score After Day 0 Day 20; n = 0, 1, 0, 0	NA mm Standard Deviation NA Subjects not available for assessment at time point	0.0 mm Standard Deviation 0	NA mm Standard Deviation NA Subjects not available for assessment at time point	NA mm Standard Deviation NA Subjects not available for assessment at time point
Ocular Pain VAS Score After Day 0 Day 21; n = 1, 0, 0, 0	0.0 mm Standard Deviation 0	NA mm Standard Deviation NA Subjects not available for assessment at time point	NA mm Standard Deviation NA Subjects not available for assessment at time point	NA mm Standard Deviation NA Subjects not available for assessment at time point
Ocular Pain VAS Score After Day 0 Day 27; n = 9, 9, 6, 5	0.6 mm Standard Deviation 1.7	0.1 mm Standard Deviation 0.3	0.0 mm Standard Deviation 0.0	0.2 mm Standard Deviation 0.4
Ocular Pain VAS Score After Day 0 Day 28; n = 11, 12, 14, 25	0.6 mm Standard Deviation 0.9	0.0 mm Standard Deviation 0.0	0.8 mm Standard Deviation 2.2	0.2 mm Standard Deviation 0.7
Ocular Pain VAS Score After Day 0 Day 29; n = 16, 14, 18, 13	0.1 mm Standard Deviation 0.3	0.1 mm Standard Deviation 0.3	1.6 mm Standard Deviation 5.1	0.0 mm Standard Deviation 0.0
Ocular Pain VAS Score After Day 0 Day 30; n = 15, 13, 6, 5	0.8 mm Standard Deviation 2.8	0.3 mm Standard Deviation 0.9	0.0 mm Standard Deviation 0.0	0.8 mm Standard Deviation 1.8
Ocular Pain VAS Score After Day 0 Day 31; n = 2, 2, 1, 3	0.0 mm Standard Deviation 0.0	0.0 mm Standard Deviation 0.0	0.0 mm Standard Deviation 0	0.0 mm Standard Deviation 0.0
Ocular Pain VAS Score After Day 0 Day 32; n = 0, 0, 5, 0	NA mm Standard Deviation NA Subjects not available for assessment at time point	NA mm Standard Deviation NA Subjects not available for assessment at time point	0.0 mm Standard Deviation 0.0	NA mm Standard Deviation NA Subjects not available for assessment at time point
Ocular Pain VAS Score After Day 0 Day 33;n = 0, 0, 2, 0	NA mm Standard Deviation NA Subjects not available for assessment at time point	NA mm Standard Deviation NA Subjects not available for assessment at time point	0.0 mm Standard Deviation 0.0	NA mm Standard Deviation NA Subjects not available for assessment at time point
Ocular Pain VAS Score After Day 0 Day 34; n = 1, 0, 0, 0	0.0 mm Standard Deviation 0	NA mm Standard Deviation NA Subjects not available for assessment at time point	NA mm Standard Deviation NA Subjects not available for assessment at time point	NA mm Standard Deviation NA Subjects not available for assessment at time point
Ocular Pain VAS Score After Day 0 Day 35; n = 1, 0, 1, 1	0.0 mm Standard Deviation 0	NA mm Standard Deviation NA Subjects not available for assessment at time point	0.0 mm Standard Deviation 0	0.0 mm Standard Deviation 0
Ocular Pain VAS Score After Day 0 Day 36; n = 1, 1, 1, 1	0.0 mm Standard Deviation 0	50.0 mm Standard Deviation 0	0.0 mm Standard Deviation 0	0.0 mm Standard Deviation 0

SECONDARY outcome

Timeframe: up to 30 days

Population: All randomized subjects

Ophthalmic anti-inflammatory medications were identified by reviewing concomitant medications. Subject incidence of ophthalmic anti-inflammatory medication use by post-surgery day was presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=56 Participants OMS302 Solution OMS302 Solution
Postoperative Use of Ophthalmic Anti-inflammatory Medications Loteprednol etabonate	0 participants	1 participants	1 participants	0 participants
Postoperative Use of Ophthalmic Anti-inflammatory Medications Bromfenac sodium	2 participants	9 participants	8 participants	6 participants
Postoperative Use of Ophthalmic Anti-inflammatory Medications Dexamethasone	1 participants	0 participants	0 participants	2 participants
Postoperative Use of Ophthalmic Anti-inflammatory Medications Difluprednate	6 participants	8 participants	7 participants	7 participants
Postoperative Use of Ophthalmic Anti-inflammatory Medications Ketorlac	0 participants	0 participants	1 participants	0 participants
Postoperative Use of Ophthalmic Anti-inflammatory Medications Ketorolac tromethamine	0 participants	1 participants	0 participants	0 participants
Postoperative Use of Ophthalmic Anti-inflammatory Medications Nepafenac	10 participants	4 participants	7 participants	4 participants
Postoperative Use of Ophthalmic Anti-inflammatory Medications Prednisolone acetate	25 participants	29 participants	28 participants	29 participants

SECONDARY outcome

Timeframe: One day

Population: All randomized subjects

Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=56 Participants OMS302 Solution OMS302 Solution
Use of Pain Medications at Day 1 Diclofenac	1 participants	0 participants	0 participants	0 participants
Use of Pain Medications at Day 1 Axotal	0 participants	0 participants	0 participants	1 participants
Use of Pain Medications at Day 1 Ibuprofen	1 participants	0 participants	1 participants	0 participants
Use of Pain Medications at Day 1 Naproxen Sodium	0 participants	0 participants	1 participants	0 participants
Use of Pain Medications at Day 1 Paracetamol	23 participants	26 participants	9 participants	18 participants
Use of Pain Medications at Day 1 Tramadol	0 participants	2 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: up to 30 days

Population: All randomized subjects

Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Outcome measures

Measure	Balanced Salt Solution (BSS) n=56 Participants Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=56 Participants OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 Participants OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=56 Participants OMS302 Solution OMS302 Solution
Use of Pain Medications After Day 1 Axotal	0 participants	0 participants	0 participants	1 participants
Use of Pain Medications After Day 1 Celecoxib	1 participants	0 participants	0 participants	0 participants
Use of Pain Medications After Day 1 Diclofenac	1 participants	0 participants	0 participants	0 participants
Use of Pain Medications After Day 1 Hydrocodone	1 participants	0 participants	0 participants	0 participants
Use of Pain Medications After Day 1 Ibuprofen	1 participants	0 participants	0 participants	0 participants
Use of Pain Medications After Day 1 Naproxen	1 participants	0 participants	0 participants	0 participants
Use of Pain Medications After Day 1 Naproxen Sodium	0 participants	0 participants	0 participants	1 participants
Use of Pain Medications After Day 1 Paracetamol	23 participants	21 participants	20 participants	29 participants
Use of Pain Medications After Day 1 Tramadol	0 participants	2 participants	0 participants	0 participants
Use of Pain Medications After Day 1 Tylox	0 participants	1 participants	0 participants	0 participants

Adverse Events

Balanced Salt Solution (BSS)

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

OMS302 Mydriatic Solution (PE)

Serious events: 1 serious events

Other events: 43 other events

Deaths: 0 deaths

OMS302 Anti-inflammatory Solution (KE)

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

OMS302 Solution

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Measure	Balanced Salt Solution (BSS) n=57 participants at risk Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=54 participants at risk OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 participants at risk OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=56 participants at risk OMS302 Solution OMS302 Solution
Nervous system disorders Facial neuralgia	0.00% 0/57 • 30 days	1.9% 1/54 • 30 days	0.00% 0/55 • 30 days	0.00% 0/56 • 30 days

Other adverse events

Measure	Balanced Salt Solution (BSS) n=57 participants at risk Balanced Salt Solution (BSS) Balanced Salt Solution (BSS)	OMS302 Mydriatic Solution (PE) n=54 participants at risk OMS302 Mydriatic Solution OMS302 Mydriatic Solution	OMS302 Anti-inflammatory Solution (KE) n=55 participants at risk OMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory Solution	OMS302 Solution n=56 participants at risk OMS302 Solution OMS302 Solution
Eye disorders Eye pain	28.1% 16/57 • 30 days	38.9% 21/54 • 30 days	23.6% 13/55 • 30 days	30.4% 17/56 • 30 days
General disorders Inflammation	22.8% 13/57 • 30 days	22.2% 12/54 • 30 days	14.5% 8/55 • 30 days	19.6% 11/56 • 30 days
Eye disorders Eye inflammation	8.8% 5/57 • 30 days	16.7% 9/54 • 30 days	21.8% 12/55 • 30 days	19.6% 11/56 • 30 days
General disorders Pain	19.3% 11/57 • 30 days	14.8% 8/54 • 30 days	14.5% 8/55 • 30 days	16.1% 9/56 • 30 days
Nervous system disorders Headache	8.8% 5/57 • 30 days	3.7% 2/54 • 30 days	7.3% 4/55 • 30 days	7.1% 4/56 • 30 days
Eye disorders Photophobia	1.8% 1/57 • 30 days	5.6% 3/54 • 30 days	3.6% 2/55 • 30 days	7.1% 4/56 • 30 days
Eye disorders Iritis	0.00% 0/57 • 30 days	3.7% 2/54 • 30 days	3.6% 2/55 • 30 days	5.4% 3/56 • 30 days

Additional Information

Chief Medical Officer

Omeros Corporation

Phone: (206) 676-5000

Email: swhitaker@omeros.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI agreed not to publish or otherwise to disclose Study data without prior written consent from the sponsor for a period of 24 months following Study completion or until data are published in a combined publication (whichever occurs first). The sponsor can review communications containing results prior to public release and embargo those communications for a period that is no longer than 60 days from the date of receipt of the non-public communication. The sponsor cannot extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER