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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

Phase 1 & 2
Waitlist Available
Research Sponsored by Livionex Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, days 30, 60, 90, and 120

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).

Eligible Conditions
  • Cataract

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, days 30, 60, 90, and 120
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, days 30, 60, 90, and 120 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Contrast Sensitivity (Mesopic) Responder Analysis
Secondary study objectives
Cumulative Improvement in Contrast Sensitivity (Mesopic)
Other study objectives
Mean Change in Best-Corrected Visual Acuity (BCVA)
Mean Change in Contrast Sensitivity (Mesopic)
Pentacam Imaging

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: C-KAD 2.6%Experimental Treatment1 Intervention
Administered four times a day (QID; no less than 3 hours apart) in both eyes for 120 days
Group II: C-KAD 1.3%Experimental Treatment1 Intervention
Administered four times a day (QID; no less than 3 hours apart) in both eyes for 120 days
Group III: PlaceboPlacebo Group1 Intervention
Administered four times a day (QID; no less than 3 hours apart) in both eyes for 120 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EDTA Ophthalmic Solution 2.6%
2006
Completed Phase 2
~120
EDTA Ophthalmic Solution 1.3%
2006
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

Livionex Inc.Lead Sponsor
3 Previous Clinical Trials
2,697 Total Patients Enrolled
~6 spots leftby Dec 2025
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