Overview

OCS-01: 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

Status:
Not yet recruiting

Trial end date:
2022-12-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to evaluate the efficacy and safety of OCS-01 Ophthalmic Suspension versus placebo (vehicle) in the treatment of inflammation and pain following cataract surgery.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Oculis

Treatments:

Dexamethasone

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.