Phase 3
Completed N=241
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
Source: ClinicalTrials.gov NCT05147233 ↗
Enrolled (actual)
241
Serious AEs
0.4%
Results posted
Jul 2025
Primary outcomePrimary: Absence of Anterior Chamber Cells at Visit 6. — 57.2; 24.0 percentage of study eyes — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
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.
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. Informational only — not medical advice.