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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8
Active Investigational Product
Control
Cornea and Cataract Consultants of Arizona
Scottsdale, Arizona, United States
Catalina Eye
Tucson, Arizona, United States
Global Research Management
Glendale, California, United States
Inland Eye Specialists
Hemet, California, United States
United Medical Research Institute
Inglewood, California, United States
North Bay Eye Associates, Inc.
Petaluma, California, United States
East West Eye Institute - Torrance
Torrance, California, United States
ICON Eye Care
Grand Junction, Colorado, United States
Advanced Vision Research Institute
Longmont, Colorado, United States
Rand Eye Institute
Deerfield Beach, Florida, United States
...and 11 more locations
BCDVA
Change from baseline in BCDVA at Weeks 4, 12, and 24.
Time frame: Baseline as compared to Weeks 4, 12, and 24.
Contrast Sensitivity
Change from baseline in contrast sensitivity at Weeks 4, 12, and 24.
Time frame: 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.
Time frame: Baseline compared to Weeks 4, 12, and 24.
Crystalline Lens Opacity
Change from baseline in crystalline lens opacity at Weeks 4, 12, and 24.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline compared to Weeks 4, 12, and 24.
Safety, AEs
AE monitoring (ocular and non-ocular)
Time frame: 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
Time frame: 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.
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