NCT06365762

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

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Livionex Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Age Related Cataracts

Interventions

Type	Name	Description
DRUG	EDTA Ophthalmic Solution 2.6%
DRUG	EDTA Ophthalmic Solution 1.3%
DRUG	Saline Solution (Placebo)

Timeline

• Start date: 2006-01-01
• Primary completion: 2006-12-31
• Completion: 2007-04-30
• First posted: 2024-04-15
• Last updated: 2024-04-16

Locations

6 sites across 1 country: United States