The Safety and Efficacy Study of Ethylenediaminetetraacetic Acid (EDTA) Ophthalmic Solution in Patients With Loss of Contrast Sensitivity Due to Age-Related, Low-Grade Nuclear Cataract

Age Related Cataracts Clinical Trial

Official title: A Phase 1/2, Randomized, Placebo-Controlled, Double-Masked, Multicenter, Dose-Ranging, Safety and Efficacy of C-KAD Ophthalmic Solution in Patients With Loss of Contrast Sensitivity Due to Age-Related, Low-Grade Nuclear Cataract

Status Completed

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Age Related Cataracts
• Cataract
• Hypersensitivity

• NCT number: NCT06365762
• Study type: Interventional
• Source: Livionex Inc.
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 1, 2006
• Completion date: April 30, 2007