A Multicenter, Randomized, Double-Masked, Placebo-Controlled Pilot Study to Evaluate the Efficacy and Safety of ZOC2017217 in Subjects With Age-Related Cataract
Overview
- Phase
- Phase 2
- Status
- Enrolling By Invitation
- Sponsor
- Ocusun Ophthalmic Pharmaceutical (Guangzhou) Co., Ltd.
- Enrollment
- 40
- Locations
- 15
- Primary Endpoint
- BCDVA
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •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.
Exclusion Criteria
- •Ocular Exclusion Criteria:
- •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 \>
- •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:
Arms & Interventions
Control
Drug with no active ingredients
Intervention: Control (Drug)
Active
ZOC2017217
Intervention: 0.4% ZOC2017217 (Drug)
Outcomes
Primary Outcomes
BCDVA
Time Frame: Baseline as compared to Weeks 4, 12, and 24.
Change from baseline in BCDVA at Weeks 4, 12, and 24.
Contrast Sensitivity
Time Frame: Baseline as compared to Weeks 4, 12, and 24.
Change from baseline in contrast sensitivity at Weeks 4, 12, and 24.
Visual Function Questionnaire (VFQ-25)
Time Frame: Baseline compared to Weeks 4, 12, and 24.
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.
Crystalline Lens Opacity
Time Frame: Baseline compared to Weeks 4, 12, and 24.
Change from baseline in crystalline lens opacity at Weeks 4, 12, and 24.
BCDVA
Time Frame: Baseline compared to Weeks 4, 12, and 24.
Proportion of subjects gaining ≥5, ≥10, or ≥15 letters from baseline in BCDVA at Weeks 4, 12, and 24.
Secondary Outcomes
- 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.)