MedDataX Logo

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

NCT ID: NCT05147233

Last Updated: 2025-07-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-24

Study Completion Date

2023-07-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

OCS-01 in Treating Inflammation and Pain in Post-cataract Patients

NCT04130802

Inflammation Corneal Pain, Postoperative
COMPLETED PHASE2

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

NCT06128369

Inflammation Eye Pain, Postoperative Cataract
TERMINATED PHASE3

Efficacy and Safety of RX-10045 Ophthalmic Solution for Ocular Inflammation and Pain in Cataract Surgery

NCT02329743

Inflammation Pain Cataract
COMPLETED PHASE2

Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)

NCT01193127

Cataract
COMPLETED PHASE2

Safety and Efficacy of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification

NCT01454063

Intraocular Lens Replacement
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammation Eye Pain Postoperative Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

OCS-01

Intervention Type DRUG

Dexamethasone ophthalmic suspension, 1.5%

Vehicle

1 drop of vehicle in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Vehicle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

OCS-01

Dexamethasone ophthalmic suspension, 1.5%

Intervention Type DRUG

Vehicle

Vehicle

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Oculis

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oculis Site 16

Chandler, Arizona, United States

Site Status

Oculis Site 28

Phoenix, Arizona, United States

Site Status

Oculis Site 8

Fayetteville, Arkansas, United States

Site Status

Oculis Site 9

Inglewood, California, United States

Site Status

Oculis Site 23

Newport Beach, California, United States

Site Status

Oculis Site 26

Petaluma, California, United States

Site Status

Oculis Site 24

San Pedro, California, United States

Site Status

Oculis Site 22

Westminster, California, United States

Site Status

Oculis Site 11

Fort Collins, Colorado, United States

Site Status

Oculis Site 12

Tamarac, Florida, United States

Site Status

Oculis Site 17

Morrow, Georgia, United States

Site Status

Oculis Site 20

Louisville, Kentucky, United States

Site Status

Oculis Site 5

St Louis, Missouri, United States

Site Status

Oculis Site 3

Washington, Missouri, United States

Site Status

Oculis Site 13

Kinston, North Carolina, United States

Site Status

Oculis Site 6

Brecksville, Ohio, United States

Site Status

Oculis Site 14

Cincinnati, Ohio, United States

Site Status

Oculis Site 25

Eugene, Oregon, United States

Site Status

Oculis Site 7

Kingston, Pennsylvania, United States

Site Status

Oculis Site 4

Austin, Texas, United States

Site Status

Oculis Site 10

Houston, Texas, United States

Site Status

Oculis Site 2

San Antonio, Texas, United States

Site Status

Oculis Site 31

San Antonio, Texas, United States

Site Status

Oculis Site 27

Salt Lake City, Utah, United States

Site Status

Oculis Site 30

Lynchburg, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DX218

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocular Inflammation and Pain Associated With Cataract Surgery
NCT00333918 COMPLETED PHASE3
Phase 2: VVN461 Ophthalmic Solution for Post -Operative Ocular Inflammation After Cataract Surgery
NCT06164743 COMPLETED PHASE2
Study to See How Well an Eye Drop, SURF-201, Works and What Side Effects There Are in Cataract Surgery Subjects
NCT04324359 COMPLETED PHASE2
A Clinical Study to Assess the Efficacy and Safety of Dexamethasone Suspension for Cataract Surgery
NCT03687931 COMPLETED PHASE1/PHASE2
Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study
NCT04810962 COMPLETED PHASE3
Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery
NCT04739709 COMPLETED PHASE3
Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
NCT02793817 COMPLETED PHASE3
Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
NCT01579565 COMPLETED PHASE3
Safety and Efficacy Study of rEV131 in the Treatment of Ocular Inflammation After Cataract Surgery
NCT00353964 UNKNOWN PHASE2
A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery (2)
NCT05550363 WITHDRAWN PHASE3
Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery
NCT01367249 COMPLETED PHASE3
No Drop Post-Op Cataract Surgery
NCT03864133 COMPLETED PHASE4
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery
NCT05626478 COMPLETED PHASE4
Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
NCT01666210 COMPLETED PHASE2
Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery
NCT00853970 COMPLETED PHASE3
A Study to Compare Ocular Safety and Tolerability of Eye Drops Containing Prednisolone Acetate in Patients With Intraocular Inflammation After Cataract Surgery
NCT00170729 COMPLETED PHASE4
The Effect of a Pre-cataract Surgical Ocular Hygiene Regime on Microbial Load, Tear Osmolarity, Dry Eye, and Inflammatory Markers
NCT05990712 UNKNOWN PHASE4
Exploratory Study of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction by Phacoemulsification.
NCT00721695 COMPLETED PHASE1/PHASE2
A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery
NCT00521456 COMPLETED PHASE3
A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
NCT05550350 WITHDRAWN PHASE3
Safety and Efficacy Study of Topical Bromfenac Versus Placebo to Treat Ocular Inflammation After Cataract Surgery
NCT00198445 COMPLETED PHASE3
A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement
NCT02132312 COMPLETED PHASE3
A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery
NCT04089735 COMPLETED PHASE2
A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery
NCT00524264 COMPLETED PHASE3
Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery
NCT04316936 COMPLETED PHASE4