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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

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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06128369
Acronym
OPTIMIZE-2
Enrollment
117
Registered
2023-11-13
Start date
2023-12-18
Completion date
2024-05-09
Last updated
2026-07-30

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.

Secondary

MeasureTime frame
Absence of Anterior Chamber Cells at Visits 4 and 5.Days 4 and 8.
Absence of Ocular Pain at Visits 3, 5, and 6.Days 2, 8, and 15.
Absence of Flare at Visits 4, 5, and 6.Days 4, 8, and 15.
Absence of Both Anterior Chamber Cells and Flare at Visits 4, 5, and 6.Days 4, 8, and 15.
Use of Rescue Medication on or Prior to Each Visit.Days 1, 2, 4, 8, 15, and 22.
Use of Rescue Medication Overall.From first dose until Day 22.

Countries

United States

Baseline characteristics

Characteristic—
Age, Continuous67.9 years
STANDARD_DEVIATION 7.6
Ethnicity (NIH/OMB)
Hispanic or Latino
16 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
34 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
3 Participants
Race (NIH/OMB)
Black or African American
9 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
93 Participants
Sex: Female, Male
Female
68 Participants
Sex: Female, Male
Male
26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 670 / 50
other
Total, other adverse events
6 / 675 / 50
serious
Total, serious adverse events
0 / 670 / 50

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026