RecruitingPhase 2NCT07395986

A Multicenter, Randomized, Double-Masked, Placebo-Controlled Pilot Study to Evaluate the Efficacy and Safety of ZOC2017217 in Subjects With Age-Related Cataract


Sponsor

Ocusun Ophthalmic Pharmaceutical (Guangzhou) Co., Ltd.

Enrollment

40 participants

Start Date

Feb 10, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, randomized, double-masked, placebo-controlled pilot study conducted in the United States (US) in subjects with age-related cataract in one or both eyes. Approximately 40 subjects with age-related cataract will be stratified by race and Best Corrected Distance Visual Acuity (BCDVA) and randomized (1:1) to active investigational product (IP) or placebo. Subjects will administer their assigned IP in both eyes, except as noted below, two times a day (BID) for 24 weeks before being exited from the study. Subjects with new or ongoing ocular adverse events (AEs) at the time of planned study exit will be asked to return 2 weeks later for a safety follow-up evaluation. The study eye will be the qualified eye that meets study eligibility criteria. Data from the study eye will be used for the purposes of efficacy analyses. Both eyes will receive treatment, except in subjects who have previously undergone cataract surgery in the non-study eye or whose non-study eye, in the opinion of the Investigator, is not suitable for treatment with the IP due to safety or another concern.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 0.4% ZOC2017217 and a drug called Control for people with age related cataracts. The study is currently recruiting participants at 21 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG0.4% ZOC2017217

Active Investigational Product

DRUGControl

Control


Locations(21)

Cornea and Cataract Consultants of Arizona

Scottsdale, Arizona, United States

Catalina Eye

Tucson, Arizona, United States

Global Research Management

Glendale, California, United States

Inland Eye Specialists

Hemet, California, United States

United Medical Research Institute

Inglewood, California, United States

North Bay Eye Associates, Inc.

Petaluma, California, United States

East West Eye Institute - Torrance

Torrance, California, United States

ICON Eye Care

Grand Junction, Colorado, United States

Advanced Vision Research Institute

Longmont, Colorado, United States

Rand Eye Institute

Deerfield Beach, Florida, United States

Levenson Eye Associates

Jacksonville, Florida, United States

Clayton Eye Clinical Research, LLC

Morrow, Georgia, United States

Springfield Clinic

Springfield, Illinois, United States

Oculus Research - Cary

Cary, North Carolina, United States

Bergstrom Eye Research

Fargo, North Dakota, United States

Cincinnati Eye Institute - Blue Ash

Blue Ash, Ohio, United States

Verum Research

Eugene, Oregon, United States

Erie Retina Research

Erie, Pennsylvania, United States

Valley Retina Institute P.A.

Laredo, Texas, United States

Valley Retina Institute P.A.

McAllen, Texas, United States

R and R Eye Research, LLC

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07395986


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