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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

Phase 3
Recruiting
Conditions
Disorders of the Eye Following Cataract Surgery
Interventions
Drug: Dexamethasone
Drug: Vehicle Placebo
Registration Number
NCT05147233
Lead Sponsor
Oculis
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
240
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]).
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Active Treatment ArmDexamethasoneOCS-01 (Ophthalmic Suspension) - topical use
Vehicle Placebo ArmVehicle PlaceboVehicle
Primary Outcome Measures
NameTimeMethod
Number of Participants With an Absence of Anterior Chamber InflammationDay 15

Absence of cells (i.e., score of ´0´) in the anterior chamber of the study eye at Day 15 (Visit 6)

Number of Participants With an Absence of Ocular PainDay 4

Absence of pain (i.e., score of ´0´) in the study eye at Day 4 (Visit 4)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Oculis Investigative Site

🇺🇸

Houston, Texas, United States

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