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

Phase 3

Completed

• Conditions: Inflammation Eye Pain; Postoperative Cataract
• Interventions: Drug: OCS-01; Drug: Vehicle

• Registration Number: NCT05147233
• Lead Sponsor: Oculis

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-24
• Study First Submitted QC: 2021-12-06
• Study First Posted: 2021-12-07
• Study Start: 2022-06-24
• Primary Completion: 2023-06-22
• Study Completion: 2023-07-03
• Status Verified: 2025-05
• Results First Submitted: 2025-06-24
• Results First Submitted QC: 2025-06-24
• Last Update Submitted: 2025-06-24
• Results First Posted: 2025-07-11
• Last Update Posted: 2025-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OCS-01	OCS-01	1 drop of OCS-01 (Dexamethasone ophthalmic suspension 1.5% \[15 mg/mL\]) in the study eye once daily (QD) for 14 days, beginning 1-day post-surgery in the study eye.
Vehicle	Vehicle	1 drop of vehicle in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.

Primary Outcome Measures

Name	Time	Method
Absence of Anterior Chamber Cells at Visit 6.	Day 15
Absence of Ocular Pain at Visit 4.	Day 4

Trial Locations

Locations (25)

Oculis Site 16; 🇺🇸 Chandler, Arizona, United States

Oculis Site 28; 🇺🇸 Phoenix, Arizona, United States

Oculis Site 8; 🇺🇸 Fayetteville, Arkansas, United States

Oculis Site 9; 🇺🇸 Inglewood, California, United States

Oculis Site 23; 🇺🇸 Newport Beach, California, United States

Oculis Site 26; 🇺🇸 Petaluma, California, United States

Oculis Site 24; 🇺🇸 San Pedro, California, United States

Oculis Site 22; 🇺🇸 Westminster, California, United States

Oculis Site 11; 🇺🇸 Fort Collins, Colorado, United States

Oculis Site 12; 🇺🇸 Tamarac, Florida, United States

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