The study objectives were: * To evaluate the efficacy of EDTA 1.3% and 2.6% ophthalmic solution (C-KAD) in improving visual function as assessed by contrast sensitivity; * To evaluate the safety and tolerability of two doses of EDTA ophthalmic solution (C-KAD); and * To determine the optimal clinical dose of EDTA ophthalmic solution (C-KAD) which to proceed into pivotal study(s).
This was a prospective, randomized, placebo-controlled, double-masked, parallel evaluation of the safety and efficacy of EDTA ophthalmic solution in patients with loss of contrast sensitivity due to age-related, low-grade cataract. 111 subjects were enrolled at six study sites within the U.S. and randomly assigned in 1:1:1 ratio to treatment with 2.6% C-KAD, 1.3% C-KAD and placebo. The treatment duration was 120 days with a run-in period and follow-up period of 14 days each. During the Run-in Period, patients received pre-treatment with lubricating eye drops (Refresh® Plus Lubricant Eye Drops) in both eyes to ensure uniformity in the level of ocular hydration at Baseline in patients randomized into the study. Patients were evaluated at a Screening Visit (Day -14), at Baseline (Day 0), during the dosing period (Days 30, 60, 90, 120) and at the Follow-up Visit (Day 134), two weeks after completion of active treatment. Tolerability and efficacy were assessed by Slit Lamp and Fundus Examinations, Best-Corrected Distance Visual Acuity, Contrast Sensitivity, Endothelial Cell Count, Pentacam Imaging, Tear Film Break-Up Time, IOP measurements, Pupil Size measurement and evaluation of Adverse Events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
111
St Mary's Eye Specialists, Inc.
San Francisco, California, United States
Hunkeler Eye Institute
Overland Park, Kansas, United States
The Johns Hopkins Hospital & Health System, Wilmer Eye Institute
Lutherville, Maryland, United States
Harvard Medical School, Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Contrast Sensitivity (Mesopic) Responder Analysis
Proportion of patients with ≥ 2-patch (0.30 logCS) contrast sensitivity improvement in at least two spatial frequencies under mesopic illumination
Time frame: Baseline, Days 30, 60, 90, and 120
Cumulative Improvement in Contrast Sensitivity (Mesopic)
total changes in patches of contrast sensitivity measurements across all five spatial frequencies (1.5, 3, 6, 12, and 18 cycles per degree)
Time frame: Baseline, Days 30, 60, 90, and 120
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Charlotte Eye, Ear, Nose, and Throat Associates
Charlotte, North Carolina, United States
University of Utah, John Moran Eye Center
Salt Lake City, Utah, United States