Trial Outcomes & Findings for RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery (NCT NCT02065375)

NCT ID: NCT02065375

Last Updated: 2025-06-03

Results Overview

Count of participants who had absence of anterior chamber cells at Day 15. White blood cells were counted. In a healthy eye, the anterior chamber should not have any blood cells present. "Yes" indicates an absence of anterior chamber cells. Data for visits after a patient was discontinued for lack of efficacy were imputed as failures and missing data were imputed using last observation carried forward.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

109 participants

Primary outcome timeframe

15 days after the participant receives the first dose

Results posted on

2025-06-03

Participant Flow

Participant milestones

Participant milestones
Measure	Omaveloxolone Ophthalmic Suspension 1.0% Patients received a single drop of Omaveloxolone Ophthalmic suspension 1.0% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery Omaveloxolone Ophthalmic Suspension 1.0%	Omaveloxolone Ophthalmic Suspension 0.5% Patients received a single drop of Omaveloxolone Ophthalmic suspension 0.5% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery Omaveloxolone Opthalmic Suspension 0.5%	Placebo Patients received a single drop of vehicle for Omaveloxolone Ophthalmic suspension instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery Placebo
Overall Study STARTED	37	33	39
Overall Study Completed Treatment	19	15	25
Overall Study COMPLETED	37	33	39
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omaveloxolone Ophthalmic Suspension 1.0% n=37 Participants Patients received a single drop of Omaveloxolone Ophthalmic suspension 1.0% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery Omaveloxolone Ophthalmic Suspension 1.0%	Omaveloxolone Ophthalmic Suspension 0.5% n=33 Participants Patients received a single drop of Omaveloxolone Ophthalmic suspension 0.5% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery Omaveloxolone Opthalmic Suspension 0.5%	Placebo n=39 Participants Patients received a single drop of vehicle for Omaveloxolone Ophthalmic suspension instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery Placebo	Total n=109 Participants Total of all reporting groups
Age, Continuous	67.9 years STANDARD_DEVIATION 9.7 • n=5 Participants	68.1 years STANDARD_DEVIATION 9.31 • n=7 Participants	68.9 years STANDARD_DEVIATION 9.47 • n=5 Participants	68.3 years STANDARD_DEVIATION 9.42 • n=4 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	18 Participants n=7 Participants	20 Participants n=5 Participants	61 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	19 Participants n=5 Participants	48 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	13 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	28 Participants n=7 Participants	37 Participants n=5 Participants	95 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	24 Participants n=7 Participants	34 Participants n=5 Participants	85 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	37 participants n=5 Participants	33 participants n=7 Participants	39 participants n=5 Participants	109 participants n=4 Participants

PRIMARY outcome

Timeframe: 15 days after the participant receives the first dose

Population: Intent-to-treat population (all randomized patients with available data). Data for visits after a patient was discontinued for lack of efficacy were imputed as failures and missing data were imputed using last observation carried forward.

Outcome measures

Outcome measures
Measure	Omaveloxolone Ophthalmic Suspension 1.0% n=37 Participants Patients will receive a single drop of Omaveloxolone Ophthalmic suspension 1.0% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery Omaveloxolone Ophthalmic Suspension 1.0%	Omaveloxolone Ophthalmic Suspension 0.5% n=33 Participants Patients will receive a single drop of Omaveloxolone Ophthalmic suspension 0.5% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery Omaveloxolone Opthalmic Suspension 0.5%	Placebo n=39 Participants Patients will receive a single drop of vehicle for Omaveloxolone Ophthalmic suspension was instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery Placebo
Absence of Anterior Chamber Cells at Day 15 (Visit 5) Yes	10 Participants	12 Participants	11 Participants
Absence of Anterior Chamber Cells at Day 15 (Visit 5) No	27 Participants	21 Participants	28 Participants

PRIMARY outcome

Timeframe: 4 days after the participant receives the first dose

Population: Intent-to-treat population (all randomized patients with available data).

Participants were asked to report their pain on Day 4 using the Numerical Pain Rating Scale (NPRS) for patients receiving active drug compared to patients receiving placebo. The NPRS is an 11-point numeric scale, which ranges from "0" representing "no pain" to "10" representing the "worst pain imaginable". Lower scores indicate less pain. Participants reporting '0' were recorded as "Yes" while patients reporting any other pain score were recorded as "No". Data for visits after a patient was discontinued for lack of efficacy were imputed as failures and missing data were imputed using last observation carried forward.