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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

NCT06365762 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2024-04-16

No results posted yet for this study

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).

Conditions

  • Age Related Cataracts

Interventions

DRUG

EDTA Ophthalmic Solution 2.6%

DRUG

EDTA Ophthalmic Solution 1.3%

DRUG

Saline Solution (Placebo)

Sponsors & Collaborators

  • Livionex Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-01
Primary Completion
2006-12-31
Completion
2007-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06365762 on ClinicalTrials.gov