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

Phase 3TerminatedNCT06128369

Oculis117 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

117

Conditions

Inflammation Eye Pain, Postoperative Cataract

Interventions

Dexamethasone Ophthalmic SuspensionDRUG

Ophthalmic Suspension,1.5% \[15 mg/mL\] Subjects will dose 1 drop of OCS-01 in the study eye once daily for 14 days, beginning 1-day post-surgery in the operated eye (administration of first dose will be performed in the clinic on Day 1).

Vehicle of OCS-01OTHER

inert vehicle of OCS-01 ophthalmic suspension Subjects will dose 1 drop of OCS-01 in the study eye once daily for 14 days, beginning 1-day post-surgery in the operated eye (administration of first dose will be performed in the clinic on Day 1).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria (Selection): * Provide written informed consent, approved by the appropriate ethics committee; * Able to comply with the study requirements and visit schedule; * At least 18 years of age of either sex or any race; * Will undergo unilateral cataract extraction via phacoemulsification and PCIOL implantation in the study eye; * Have an anterior chamber cell score ≥ 2 at Visit 2 (Day 1 \[18 to 30 hours post- uncomplicated cataract surgery without vitreous loss\]); 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

Locations (12)

Oculis Investigative Site

Inglewood, California, United States

Oculis Investigative Site

Morrow, Georgia, United States

Oculis Investigative Site

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

To evaluate the efficacy of OCS-01 to control inflammation in subjects after cataract surgery

Absence of anterior chamber cells (i.e. score of '0')

Time frame: Visit 6 (Day 15)

To evaluate the efficacy of OCS-01 to control pain in subjects after cataract surgery

Absence of pain (i.e. score of '0')

Time frame: Visit 4 (Day 4)

Data from ClinicalTrials.gov

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