Study Evaluating the Efficacy and Safety of OCS-01 Eye Drops in Subjects Following Cataract Surgery

Phase 3

Terminated

• Conditions: Inflammation Eye; Cataract; Pain, Postoperative
• Interventions: Other: Vehicle of OCS-01; Drug: Dexamethasone Ophthalmic Suspension

• Registration Number: NCT06128369
• Lead Sponsor: Oculis

Brief Summary

The goal of this clinical trial is to evaluate the efficacy and safety of OCS-01 in treating inflammation and pain in subjects following cataract surgery.

Detailed Description

This is a multi-center, randomized, double-masked, vehicle-controlled study, designed to evaluate the efficacy and safety of OCS-01 compared to vehicle in treating inflammation and pain following cataract surgery. Subjects will be randomized 1:1 to receive OCS-01 or vehicle once daily.

Study Timeline

• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-07
• Study First Posted: 2023-11-13
• Study Start: 2023-12-18
• Primary Completion: 2024-05-02
• Study Completion: 2024-05-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

Not provided

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Exclusion Criteria

• Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the study medication's components;
• Have only one functional eye (monocular);
• 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 *Additional inclusion/exclusion criteria apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle ophthalmic suspension	Vehicle of OCS-01	Vehicle of OCS-01
OCS-01	Dexamethasone Ophthalmic Suspension	dexamethasone ophthalmic suspension,1.5% \[15 mg/mL\]

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of OCS-01 to control inflammation in subjects after cataract surgery	Visit 6 (Day 15)	Absence of anterior chamber cells (i.e. score of '0')
To evaluate the efficacy of OCS-01 to control pain in subjects after cataract surgery	Visit 4 (Day 4)	Absence of pain (i.e. score of '0')

Trial Locations

Locations (1)

Oculis Investigative Site; 🇺🇸 Lynchburg, Virginia, United States