Phase 3 N=241 Randomized Double-blind Treatment

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

Inflammation Eye Pain · Postoperative Cataract

Bottom Line

View on ClinicalTrials.gov: NCT05147233 ↗

Enrolled (actual)

241

Serious AEs

0.4%

Results posted

Jul 2025

Primary outcome: Primary: Absence of Anterior Chamber Cells at Visit 6. — 57.2; 24.0 percentage of study eyes — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: OCS-01 (Drug); Vehicle (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Oculis
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Absence of Anterior Chamber Cells at Visit 6.	57.2; 24.0	<0.0001 sig
PRIMARY Absence of Ocular Pain at Visit 4.	75.5; 52.0	<0.0001 sig

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05147233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.