Age Related Cataracts
Conditions
Keywords
Cataract, Cataracts, Age related cataract
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 both eyes, except as noted below, 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. The study eye will be the qualified eye that meets study eligibility criteria. Data from the study eye will be used for the purposes of efficacy analyses. Both eyes will receive treatment, except in subjects who have previously undergone cataract surgery in the non-study eye or whose non-study eye, in the opinion of the Investigator, is not suitable for treatment with the IP due to safety or another concern.
Interventions
DRUG0.4% ZOC2017217
Active Investigational Product
DRUGControl
Control
Sponsors
Ocusun Ophthalmic Pharmaceutical (Guangzhou) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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 ≤67 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BCDVA | Baseline as compared to Weeks 4, 12, and 24. | Change from baseline in BCDVA at Weeks 4, 12, and 24. |
| Contrast Sensitivity | 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) | 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 | Baseline compared to Weeks 4, 12, and 24. | Change from baseline in crystalline lens opacity at Weeks 4, 12, and 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | AE monitoring (ocular and non-ocular) |
| 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. | 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 |
Countries
United States
Outcome results
None listed