CompletedPhase 1/2

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

United States111 participantsStarted 2006-01-01

Plain-language 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).

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female patients ≥ 50 years of age * Presence of early nuclear sclerosis cataract in both eyes below the level recommended for surgical replacement * Both eyes having contrast sensitivity measurements of: * Screening Visit: * Less than or equal to 6, 4 and 4 in spatial frequencies C, D and E, respectively under mesopic illumination * Baseline Visit: * Less than or equal to 6, 4 and 4 in spatial frequencies C, D and E, respectively under mesopic illumination and * Greater than 0 in all five spatial frequencies (Patches A, B, C, D and E) under photopic illumination * Best-Corrected Distance Visual Acuity (BCDVA) measurement by ETDRS of better than or equal to 20/50 in both eyes attributable to low- grade nuclear cataract * Patient must be willing and able to provide written informed consent * Patient must be willing and able to comply with study visits as described in the protocol Exclusion Criteria: * Clinical evidence of any active ocular infection (i.e., bacterial, viral, parasitic or fungal) in either eye * History of herpetic ocular infection in either eye * Presence or history of glaucoma in either eye * Presence or history of intraocular pressure of \>22 mm Hg in either eye * Amblyopia in either eye * Presence of any corneal disorder including pterygium or superficial keratitis * Dry eyes which require the use of a prescription medication * Presence of posterior subcapsular cataract * Presence of cortical cataract that intrudes …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Contrast Sensitivity (Mesopic) Responder Analysis

Timeframe: Baseline, Days 30, 60, 90, and 120

Trial details

NCT IDNCT06365762

SponsorLivionex Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-12-31

View on ClinicalTrials.gov More Age Related Cataracts trials