A Multicenter, Randomized, Double-Masked, Placebo-Controlled Pilot Study to Evaluate the Efficacy… (NCT07395986) | Clinical Trial Compass
By InvitationPhase 2
A Multicenter, Randomized, Double-Masked, Placebo-Controlled Pilot Study to Evaluate the Efficacy and Safety of ZOC2017217 in Subjects With Age-Related Cataract
United States40 participantsStarted 2026-02-10
Plain-language 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 the qualifying eye(s) 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.
Who can participate
Age range50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Are ≥50 years of age.
✓. Willing and able to provide informed consent and provide relevant privacy authorization(s).
✓. Willing and able to comply with study requirements and visit schedule.
✓. Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution.
✓. Have high-contrast BCDVA under photopic conditions ≥35 letters and ≤61 letters at Visit 1 (Screening).
✓. Have calculated baseline BCDVA at Visit 2 (Randomization; Baseline; Day 1) that simultaneously meets Randomization Criteria.
✓. Have, in the opinion of the Investigator, age-related cataract (cortical, nuclear, posterior, mixed) in one or both eyes, as assessed using digital imaging after adequate mydriasis.
✓. Have, in the opinion of the Investigator, sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging.
Exclusion criteria
What they're measuring
1
BCDVA
Timeframe: Baseline as compared to Weeks 4, 12, and 24.
2
Contrast Sensitivity
Timeframe: Baseline as compared to Weeks 4, 12, and 24.
3
Visual Function Questionnaire (VFQ-25)
Timeframe: Baseline compared to Weeks 4, 12, and 24.
4
Crystalline Lens Opacity
Timeframe: Baseline compared to Weeks 4, 12, and 24.
5
BCDVA
Timeframe: Baseline compared to Weeks 4, 12, and 24.
6
BCDVA
Timeframe: Baseline compared to Weeks 4, 12, and 24.
7
BCDVA
Timeframe: Baseline compared to Weeks 4, 12, and 24.
✕. Have a history of intraocular surgery, laser treatment, or corneal surgery. Note: Corneal refractive surgery more than 2 years prior to Visit 1 (Screening) is allowed.
✕. Have, in the opinion of the Investigator, a cataract other than age-related cataract (e.g., traumatic, concurrent, metabolic, drug and toxic, radiation).
✕. Have, in the opinion of the Investigator, any ocular disease or condition that is not stably controlled or is likely to affect central vision, including but not limited to:
✕. Have overall CFS \>3.
✕. Have active eye infection or inflammation, including but not limited to conjunctivitis, keratitis, scleritis, or endophthalmitis.
✕. Have high-contrast BCDVA under photopic conditions ≤19 letters.
✕. Have planned or be planning to undergo cataract surgery during the study. Note: A history of cataract surgery in the non-study eye is allowed for subjects who commit to not undergoing additional cataract surgery during the study.