Trial Outcomes & Findings for A Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery (NCT NCT05147233)
NCT ID: NCT05147233
Last Updated: 2025-07-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
241 participants
Primary outcome timeframe
Day 15
Results posted on
2025-07-11
Participant Flow
Participant milestones
| Measure |
OCS-01
1 drop of OCS-01 in the study eye once QD for 14 days, beginning 1-day post-surgery in the study eye.
|
Vehicle
1 drop of vehicle in the study eye once QD for 14 days, beginning 1-day post-surgery in the study eye.
|
|---|---|---|
|
Overall Study
STARTED
|
119
|
122
|
|
Overall Study
COMPLETED
|
116
|
118
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
OCS-01
1 drop of OCS-01 in the study eye once QD for 14 days, beginning 1-day post-surgery in the study eye.
|
Vehicle
1 drop of vehicle in the study eye once QD for 14 days, beginning 1-day post-surgery in the study eye.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
A Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Baseline characteristics by cohort
| Measure |
OCS-01
n=119 Participants
1 drop of OCS-01 in the study eye once QD for 14 days, beginning 1-day post-surgery in the study eye.
|
Vehicle
n=122 Participants
1 drop of vehicle in the study eye once QD for 14 days, beginning 1-day post-surgery in the study eye.
|
Total
n=241 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.8 Years
STANDARD_DEVIATION 7.80 • n=5 Participants
|
67.8 Years
STANDARD_DEVIATION 8.98 • n=7 Participants
|
68.3 Years
STANDARD_DEVIATION 8.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
95 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: FAS
Outcome measures
| Measure |
OCS-01
n=119 study eye
1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.
|
Vehicle
n=122 study eye
1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.
|
|---|---|---|
|
Absence of Anterior Chamber Cells at Visit 6.
|
57.2 percentage of study eyes
|
24.0 percentage of study eyes
|
PRIMARY outcome
Timeframe: Day 4Population: FAS
Outcome measures
| Measure |
OCS-01
n=119 study eye
1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.
|
Vehicle
n=122 study eye
1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.
|
|---|---|---|
|
Absence of Ocular Pain at Visit 4.
|
75.5 percentage of study eyes
|
52.0 percentage of study eyes
|
Adverse Events
OCS-01
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Vehicle
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OCS-01
n=119 participants at risk
1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.
|
Vehicle
n=122 participants at risk
1 drop of vehicle in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.
|
|---|---|---|
|
Infections and infestations
Covid-19
|
0.00%
0/119 • From first dose until Day 90
|
0.82%
1/122 • Number of events 1 • From first dose until Day 90
|
Other adverse events
| Measure |
OCS-01
n=119 participants at risk
1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.
|
Vehicle
n=122 participants at risk
1 drop of vehicle in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.
|
|---|---|---|
|
Eye disorders
Eye Pain
|
1.7%
2/119 • Number of events 2 • From first dose until Day 90
|
6.6%
8/122 • Number of events 8 • From first dose until Day 90
|
Additional Information
Sharon Klier, M.D., M.S., M.P.H, Chief Development Officer
OCULIS Operations SàrI
Phone: +41 21 711 3970
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60