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

Conditions

• Age Related Cataracts

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 0.4% ZOC2017217 — DRUG
  Active Investigational Product
• Control — DRUG
  Control

Study Details

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.

Key Dates

First listed

Feb 9, 2026

Start date

Feb 10, 2026

Status verified

Aug 2026

Primary completion

Feb 28, 2027

Completion

Feb 28, 2027

Study Design

Enrollment

8 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Control
  Drug with no active ingredients
• Experimental: Active
  ZOC2017217

Primary Outcome Measure

BCDVA [ Time Frame: Baseline as compared to Weeks 4, 12, and 24. ]

Locations (21)

Find similar trials in Scottsdale, AZ

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