Trial Outcomes & Findings for A Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Opthalmic Suspension Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery (NCT NCT06128369)
NCT ID: NCT06128369
Last Updated: 2026-07-30
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
117 participants
Primary outcome timeframe
Day 15.
Results posted on
2026-07-30
Participant Flow
Participant milestones
| Measure |
OCS-01
1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery.
|
Vehicle
1 drop of vehicle in the study eye QD for 14 days, beginning 1-day post-surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
50
|
|
Overall Study
COMPLETED
|
67
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Opthalmic Suspension Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Baseline characteristics by cohort
| Measure |
OCS-01
n=67 Participants
1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery.
|
Vehicle
n=50 Participants
1 drop of vehicle in the study eye QD for 14 days, beginning 1-day post-surgery.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 7.60 • n=20 Participants
|
67.0 years
STANDARD_DEVIATION 7.93 • n=20 Participants
|
67.5 years
STANDARD_DEVIATION 7.72 • n=40 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=20 Participants
|
27 Participants
n=20 Participants
|
68 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=20 Participants
|
23 Participants
n=20 Participants
|
49 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
41 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=20 Participants
|
34 Participants
n=20 Participants
|
76 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=20 Participants
|
40 Participants
n=20 Participants
|
93 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Day 15.Population: Analyses were performed based on the actual treatment received, using observed data.
Outcome measures
| Measure |
OCS-01
n=67 Participants
1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery.
|
Vehicle
n=50 Participants
1 drop of Vehicle in the study eye QD for 14 days, beginning 1-day post-surgery.
|
|---|---|---|
|
Absence of Anterior Chamber Cells at Visit 6.
|
40 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Day 4.Population: Analyses were performed based on the actual treatment received, using observed data.
Outcome measures
| Measure |
OCS-01
n=67 Participants
1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery.
|
Vehicle
n=50 Participants
1 drop of Vehicle in the study eye QD for 14 days, beginning 1-day post-surgery.
|
|---|---|---|
|
Absence of Ocular Pain at Visit 4.
|
51 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Days 4 and 8.Population: Analyses were performed based on the actual treatment received, using observed data.
Outcome measures
| Measure |
OCS-01
n=67 Participants
1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery.
|
Vehicle
n=50 Participants
1 drop of Vehicle in the study eye QD for 14 days, beginning 1-day post-surgery.
|
|---|---|---|
|
Absence of Anterior Chamber Cells at Visits 4 and 5.
Absence of Anterior Chamber Cells at Visit 4
|
8 Participants
|
2 Participants
|
|
Absence of Anterior Chamber Cells at Visits 4 and 5.
Absence of Anterior Chamber Cells at Visit 5
|
17 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Days 2, 8, and 15.Population: Analyses were performed based on the actual treatment received, using observed data.
Outcome measures
| Measure |
OCS-01
n=67 Participants
1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery.
|
Vehicle
n=50 Participants
1 drop of Vehicle in the study eye QD for 14 days, beginning 1-day post-surgery.
|
|---|---|---|
|
Absence of Ocular Pain at Visits 3, 5, and 6.
Absence of Ocular Pain at Visit 3
|
43 Participants
|
23 Participants
|
|
Absence of Ocular Pain at Visits 3, 5, and 6.
Absence of Ocular Pain at Visit 5
|
59 Participants
|
32 Participants
|
|
Absence of Ocular Pain at Visits 3, 5, and 6.
Absence of Ocular Pain at Visit 6
|
67 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Days 4, 8, and 15.Population: Analyses were performed based on the actual treatment received, using observed data.
Outcome measures
| Measure |
OCS-01
n=67 Participants
1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery.
|
Vehicle
n=50 Participants
1 drop of Vehicle in the study eye QD for 14 days, beginning 1-day post-surgery.
|
|---|---|---|
|
Absence of Flare at Visits 4, 5, and 6.
Absence of Flare at Visit 6
|
66 Participants
|
44 Participants
|
|
Absence of Flare at Visits 4, 5, and 6.
Absence of Flare at Visit 4
|
47 Participants
|
31 Participants
|
|
Absence of Flare at Visits 4, 5, and 6.
Absence of Flare at Visit 5
|
53 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Days 4, 8, and 15.Population: Analyses were performed based on the actual treatment received, using observed data.
Outcome measures
| Measure |
OCS-01
n=67 Participants
1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery.
|
Vehicle
n=50 Participants
1 drop of Vehicle in the study eye QD for 14 days, beginning 1-day post-surgery.
|
|---|---|---|
|
Absence of Both Anterior Chamber Cells and Flare at Visits 4, 5, and 6.
Absence of Both Anterior Chamber Cells and Flare at Visit 4
|
8 Participants
|
1 Participants
|
|
Absence of Both Anterior Chamber Cells and Flare at Visits 4, 5, and 6.
Absence of Both Anterior Chamber Cells and Flare at Visit 5
|
17 Participants
|
4 Participants
|
|
Absence of Both Anterior Chamber Cells and Flare at Visits 4, 5, and 6.
Absence of Both Anterior Chamber Cells and Flare at Visit 6
|
40 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Days 1, 2, 4, 8, 15, and 22.Population: Analyses were performed based on the actual treatment received, using observed data.
Outcome measures
| Measure |
OCS-01
n=67 Participants
1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery.
|
Vehicle
n=50 Participants
1 drop of Vehicle in the study eye QD for 14 days, beginning 1-day post-surgery.
|
|---|---|---|
|
Use of Rescue Medication on or Prior to Each Visit.
Use of Rescue Medication at Visit 2
|
0 Participants
|
0 Participants
|
|
Use of Rescue Medication on or Prior to Each Visit.
Use of Rescue Medication at Visit 3
|
0 Participants
|
1 Participants
|
|
Use of Rescue Medication on or Prior to Each Visit.
Use of Rescue Medication at Visit 4
|
1 Participants
|
2 Participants
|
|
Use of Rescue Medication on or Prior to Each Visit.
Use of Rescue Medication at Visit 5
|
6 Participants
|
20 Participants
|
|
Use of Rescue Medication on or Prior to Each Visit.
Use of Rescue Medication at Visit 6
|
11 Participants
|
29 Participants
|
|
Use of Rescue Medication on or Prior to Each Visit.
Use of Rescue Medication at Visit 7
|
16 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: From first dose until Day 22.Population: Analyses were performed based on the actual treatment received, using observed data.
Outcome measures
| Measure |
OCS-01
n=67 Participants
1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery.
|
Vehicle
n=50 Participants
1 drop of Vehicle in the study eye QD for 14 days, beginning 1-day post-surgery.
|
|---|---|---|
|
Use of Rescue Medication Overall.
|
16 Participants
|
30 Participants
|
Adverse Events
OCS-01
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OCS-01
n=67 participants at risk
1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery.
|
Vehicle
n=50 participants at risk
1 drop of vehicle in the study eye QD for 14 days, beginning 1-day post-surgery.
|
|---|---|---|
|
Eye disorders
Eye inflammation
|
9.0%
6/67 • Number of events 6 • From first dose until Day 22.
|
10.0%
5/50 • Number of events 5 • From first dose until Day 22.
|
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