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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

A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle in the Treatment of Inflammation and Pain Following Cataract Surgery

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05147233
Acronym
OPTIMIZE-1
Enrollment
241
Registered
2021-12-07
Start date
2022-06-24
Completion date
2023-07-03
Last updated
2025-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation Eye Pain, Postoperative Cataract

Brief summary

This was a randomized, double-masked, vehicle-controlled, Phase 3 study evaluating the efficacy and safety of OCS-01 QD compared to vehicle in the treatment of inflammation and pain following cataract surgery.

Interventions

DRUGOCS-01

Dexamethasone ophthalmic suspension, 1.5%

DRUGVehicle

Vehicle

Sponsors

Oculis
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Be planning to undergo unilateral cataract extraction via phacoemulsification and posterior chamber intraocular lens (PCIOL) implantation in the study eye. * Have a pin-hole visual acuity (VA) without any other correction \> 20 letters (approximately 20/400) in the operative eye and \> 35 letters (approximately 20/200) in the fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at Visit 1 (Day -1 to Day -28 \[prior to surgery\]).

Exclusion criteria

* Have any intraocular inflammation (e.g. white blood cells or flare) present in either eye at the Visit 1 (Day -1 to Day -28 \[prior to surgery\]) slit lamp examination. * Have a score \> 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 \[prior to surgery\]) in the study eye.

Design outcomes

Primary

MeasureTime frame
Absence of Anterior Chamber Cells at Visit 6.Day 15
Absence of Ocular Pain at Visit 4.Day 4

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
119
Vehicle
1 drop of vehicle in the study eye once QD for 14 days, beginning 1-day post-surgery in the study eye.
122
Total241

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event01
Overall StudyLost to Follow-up11
Overall StudyProtocol Violation01
Overall StudyWithdrawal by Subject21

Baseline characteristics

CharacteristicOCS-01VehicleTotal
Age, Continuous68.8 Years
STANDARD_DEVIATION 7.8
67.8 Years
STANDARD_DEVIATION 8.98
68.3 Years
STANDARD_DEVIATION 8.42
Ethnicity (NIH/OMB)
Hispanic or Latino
26 Participants26 Participants52 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
93 Participants96 Participants189 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
6 Participants5 Participants11 Participants
Race (NIH/OMB)
Black or African American
17 Participants25 Participants42 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
95 Participants91 Participants186 Participants
Sex: Female, Male
Female
71 Participants70 Participants141 Participants
Sex: Female, Male
Male
48 Participants52 Participants100 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1190 / 122
other
Total, other adverse events
2 / 1198 / 122
serious
Total, serious adverse events
0 / 1191 / 122

Outcome results

Primary

Absence of Anterior Chamber Cells at Visit 6.

Time frame: Day 15

Population: FAS

ArmMeasureValue (NUMBER)
OCS-01Absence of Anterior Chamber Cells at Visit 6.57.2 percentage of study eyes
VehicleAbsence of Anterior Chamber Cells at Visit 6.24.0 percentage of study eyes
p-value: <0.000195% CI: [21.5, 44.9]Wald test
Primary

Absence of Ocular Pain at Visit 4.

Time frame: Day 4

Population: FAS

ArmMeasureValue (NUMBER)
OCS-01Absence of Ocular Pain at Visit 4.75.5 percentage of study eyes
VehicleAbsence of Ocular Pain at Visit 4.52.0 percentage of study eyes
p-value: <0.000195% CI: [11.7, 35.3]Wald test

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026