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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Age Related Cataracts
• Intervention / Treatment: Drug: Control; Drug: 0.4% ZOC2017217

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Cornea and Cataract Consultants of Arizona
    • Tucson, Arizona, United States, 85712
      • Catalina Eye
  • California
    • Glendale, California, United States, 91204
      • Global Research Management
    • Hemet, California, United States, 92545
      • Inland Eye Specialists
    • Inglewood, California, United States, 90301
      • United Medical Research Institute
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates, Inc.
    • Torrance, California, United States, 90505
      • East West Eye Institute - Torrance
  • Colorado
    • Grand Junction, Colorado, United States, 81501
      • ICON Eye Care
    • Longmont, Colorado, United States, 80503
      • Advanced Vision Research Institute
  • Florida
    • Deerfield Beach, Florida, United States, 33064
      • Rand Eye Institute
    • Jacksonville, Florida, United States, 32204
      • Levenson Eye Associates
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Clinical Research, LLC
  • Illinois
    • Springfield, Illinois, United States, 62703
      • Springfield Clinic
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Oculus Research - Cary
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Bergstrom Eye Research
  • Ohio
    • Blue Ash, Ohio, United States, 45242
      • Cincinnati Eye Institute - Blue Ash
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Verum Research
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16505
      • Erie Retina Research
  • Texas
    • Laredo, Texas, United States, 78041
      • Valley Retina Institute P.A.
    • McAllen, Texas, United States, 78503
      • Valley Retina Institute P.A.
    • San Antonio, Texas, United States, 78229
      • R and R Eye Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Inclusion Criteria:

  1. Are ≥50 years of age.
  2. Willing and able to provide informed consent and provide relevant privacy authorization(s).
  3. Willing and able to comply with study requirements and visit schedule.
  4. Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution.
  5. Have high-contrast BCDVA under photopic conditions ≥35 letters and ≤61 letters at Visit 1 (Screening).
  6. Have calculated baseline BCDVA at Visit 2 (Randomization; Baseline; Day 1) that simultaneously meets Randomization Criteria.

  7. 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

  8. Have, in the opinion of the Investigator, sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging.

Exclusion Criteria:

• Ocular Exclusion Criteria:

Study Eye:

1. Have a history of ocular trauma.
2. 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.
3. Have, in the opinion of the Investigator, a cataract other than age-related cataract (e.g., traumatic, concurrent, metabolic, drug and toxic, radiation).

4. 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)

5. Have overall CFS >3.

6. 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:

7. Have high-contrast BCDVA under photopic conditions ≤19 letters.

   Either Eye:

8. 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.
9. Have newly developed or not stably controlled uveitis within the 6 months prior to Visit 1 (Screening).
10. Unwilling or unable to discontinue wearing contact lenses 14 days prior to Visit 2 (Randomization; Baseline; Day 1), and during the study conduct.

11. Requires, is likely to require, or is unwilling to discontinue the use of prohibited medications or procedures within 14 days prior to Visit 1 (Screening), or during the study conduct.

    A. Other ocular surgeries that may affect visual function, including but not limited to photodynamic therapy. B. Desferrioxamine, hydroxychloroquine, chloroquine, tamoxifen, phenothiazines, ethambutol, or other agents known to cause crystalline lens, retinal, or optic nerve toxicity.

    C. Chlorpromazine or corticosteroids that may aggravate crystalline lens opacity.

    Note: Topical non-ocular corticosteroids are allowed.

    General Exclusion Criteria:

12. Have a severe or not stably controlled systemic disease that may interfere with study participation or confound interpretability (e.g., acute phase of chronic obstructive pulmonary disease; congestive heart failure; severe hepatic or renal insufficiency; malignant tumors currently being treated with chemotherapy).
13. Have diabetes mellitus with HbA1c ≥7.5%.
14. Have hypertension that is not stably controlled at Visit 1 (Screening) A. Systolic blood pressure: >180 mmHg B. Diastolic blood pressure: >100 mmHg after standard of care
15. Have participated or are planning to participate in a clinical study for an investigational drug/medical device within 30 days prior to Visit 1 (Screening), or during the study conduct.
16. Are pregnant, nursing, or planning a pregnancy during the study.
17. Unwilling or unable to use an acceptable method of contraception throughout the study if a woman of childbearing potential (WOCBP).
18. Unwilling or unable to use an acceptable method of contraception throughout the study if a male sexual partner of a WOCBP.
19. Have a family member or household member enrolled in the study.
20. Have any condition, in the opinion of the Investigator, that makes the subject unsuitable for study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Drug with no active ingredients	Drug: Control; Control
Experimental: Active; ZOC2017217	Drug: 0.4% ZOC2017217; Active Investigational Product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety, AEs	AE monitoring (ocular and non-ocular)	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	Clinically relevant changes from baseline in the following: Vital signs Slit-lamp biomicroscopy Corneal fluorescein staining (CFS)-National Eye Institute (NEI) Grading Scale Corneal endothelial cell count Intraocular pressure (IOP) Dilated fundus examination	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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Cataract; Cataracts; Age related cataract
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: GOCS-H101-E06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No