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OpenTrials
Completed

NCT Number: NCT05147233

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

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.

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Key information

Conditions

Inflammation Eye Pain Postoperative Cataract

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Oculis Site 16, Chandler, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OCS-01

Drug

Dexamethasone ophthalmic suspension, 1.5%

Vehicle

Drug

Vehicle

Primary outcomes

  1. Absence of Anterior Chamber Cells at Visit 6.

    Time frame: Day 15

  2. Absence of Ocular Pain at Visit 4.

    Time frame: Day 4

Sponsors and collaborators

Lead sponsor

Oculis

Industry

Registry information

Official study title

A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle in the Treatment of Inflammation and Pain Following Cataract Surgery

Acronym: OPTIMIZE-1

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2021
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.