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

NCT07395986 | Enrolling By Invitation Phase 2 FDA Drug

• 1 other identifier: GOCS-H101-E06
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

Age Related Cataracts

Keywords

Cataract; Cataracts; Age related cataract

Outcome Measures

Primary Outcomes (7)

• BCDVA

  Change from baseline in BCDVA at Weeks 4, 12, and 24.

  Baseline as compared to Weeks 4, 12, and 24.

• Contrast Sensitivity

  Change from baseline in contrast sensitivity at Weeks 4, 12, and 24.

  Baseline as compared to Weeks 4, 12, and 24.

• Visual Function Questionnaire (VFQ-25)

  Change from baseline in Visual Function Questionnaire (VFQ-25) scores at Weeks 4, 12, and 24. VFQ-25 score total should increase from the baseline visit to show better visual function at Weeks 4, 12, and 24.

  Baseline compared to Weeks 4, 12, and 24.

• Crystalline Lens Opacity

  Change from baseline in crystalline lens opacity at Weeks 4, 12, and 24.

  Baseline compared to Weeks 4, 12, and 24.

• BCDVA

  Proportion of subjects gaining ≥5, ≥10, or ≥15 letters from baseline in BCDVA at Weeks 4, 12, and 24.

  Baseline compared to Weeks 4, 12, and 24.

• BCDVA

  Proportion of subjects losing ≤5, ≤10, or ≤15 letters from baseline in BCDVA at Weeks 4, 12, and 24.

  Baseline compared to Weeks 4, 12, and 24.

• BCDVA

  Proportion of subjects achieving BCDVA ≥0.3, 0.1, or 0.0 Logarithm of the Minimum Angle of Resolution (LogMAR; Snellen: 20/40, 20/25, or 20/20) at Weeks 4, 12, and 24.

  Baseline compared to Weeks 4, 12, and 24.

Secondary Outcomes (2)

• Safety, AEs

  From the start of use of the IP at Visit 2 (Day 1) to the time the subject is exited after Visit 6 procedures and assessments are conducted. Visit 6 is conducted 2 weeks after the last dose is given at Week 24.

• Safety, Clinically Relevant Changes

  From the start of use of the IP at Visit 2 (Day 1) to the time the subject is exited after Visit 6 procedures and assessments are conducted. Visit 6 is conducted 2 weeks after the last dose is given at Week 24.

Study Arms (2)

Control

PLACEBO COMPARATOR

Drug with no active ingredients

Drug: Control

Active

EXPERIMENTAL

ZOC2017217

Drug: 0.4% ZOC2017217

Interventions

Control DRUG

Control

Control

0.4% ZOC2017217 DRUG

Active Investigational Product

Active

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• A. C \< 5.0 B. N \< 5.0 (both nuclear opalescence \[NO\] and nuclear color \[NC\]) C. P \< 1.0
• Have, in the opinion of the Investigator, sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging.

You may not qualify if:

• Study Eye:
• Have a history of ocular trauma.
• 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:
• Glaucoma Elevated IOP (e.g., ≥30 mmHg) Optic neuropathy Age-related macular degeneration Diabetic retinopathy Retinal artery or vein occlusion Macular hole Retinal detachment Epiretinal membrane involving the fovea High myopia (i.e., spherical equivalent of subjective refraction ≥ -7.0 D) High hyperopia (i.e., spherical equivalent of subjective refraction \> +4.00 D)
• Have overall CFS \>3.
• Have active eye infection or inflammation, including but not limited to conjunctivitis, keratitis, scleritis, or endophthalmitis.
• Note: Mild inflammation (CFS \<3 on the NEI scale) from ocular surface disease, including dry eye disease, is allowed.
• Non-study Eye:
• Have high-contrast BCDVA under photopic conditions ≤19 letters.
• Either Eye:
• 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.
• Have newly developed or not stably controlled uveitis within the 6 months prior to Visit 1 (Screening).
• Unwilling or unable to discontinue wearing contact lenses 14 days prior to Visit 2 (Randomization; Baseline; Day 1), and during the study conduct.

Sponsors & Collaborators

• Ocusun Ophthalmic Pharmaceutical (Guangzhou) Co., Ltd.: lead

Study Sites (17)

Catalina Eye

Tucson, Arizona, 85712, United States

Location

Global Research Management

Glendale, California, 91204, United States

Location

Inland Eye Specialists

Hemet, California, 92545, United States

Location

United Medical Research Institute

Inglewood, California, 90301, United States

Location

North Bay Eye Associates, Inc.

Petaluma, California, 94954, United States

Location

East West Eye Institute - Torrance

Torrance, California, 90505, United States

Location

ICON Eye Care

Grand Junction, Colorado, 81501, United States

Location

Advanced Vision Research Institute

Longmont, Colorado, 80503, United States

Location

Rand Eye Institute

Deerfield Beach, Florida, 33064, United States

Location

Levenson Eye Associates

Jacksonville, Florida, 32204, United States

Location

Clayton Eye Clinical Research, LLC

Morrow, Georgia, 30260, United States

Location

Oculus Research - Cary

Cary, North Carolina, 27518, United States

Location

Bergstrom Eye Research

Fargo, North Dakota, 58103, United States

Location

Cincinnati Eye Institute - Blue Ash

Blue Ash, Ohio, 45242, United States

Location

Erie Retina Research

Erie, Pennsylvania, 16505, United States

Location

Valley Retina Institute P.A.

McAllen, Texas, 78503, United States

Location

R and R Eye Research, LLC

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 9, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (17)