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Enrolling By Invitation
NCT07395986
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
Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 40
Sponsor: Ocusun Ophthalmic Pharmaceutical (Guangzhou) Co., Ltd.
Location: Cornea and Cataract Consultants of Arizona Scottsdale Arizona
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.
Eligibility Criteria
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 \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.
Source: ClinicalTrials.gov (NCT07395986). StuddyBuddy aggregates publicly available trial information.