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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Age Related Cataracts

In brief

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).

Key facts

Study ID

NCT06365762

Run by

Livionex Inc.

People needed

111

Starts

2006-01-01

Expected to finish

2007-04-30

Last updated by the study team

2024-04-16

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 within the central 4mm of the lens
• Presence or history of any ocular inflammatory disorder in either eye (e.g., uveitis, ocular allergies)
• Patients with known allergies to EDTA preservatives
• Presence of any optic nerve or retinal disorders including, but not limited to, age-related macular degeneration, optic neuropathy, etc. in either eye
• Prior intraocular, refractive and/or laser surgery of any type in either eye
• Anticipated need for ocular surgery in either eye within six months of study enrollment
• History of diabetes
• Pseudo-exfoliation syndrome
• Contact lens use (soft contact lens wear within 2 weeks of the date of randomization, rigid lens wear within three months of the date of randomization. No contact lens use throughout duration of the study)
• Current use or anticipated use of any ocular medications (over-the- counter or prescription). Use of topical ophthalmic drugs should be discontinued 14 days prior to enrollment into the treatment arm of the study
• Current or anticipated use of any systemic or ocular steroids or chronic use of topical steroids within 30 days of study enrollment
• Females who are pregnant, lactating or pre- or peri menopausal and unwilling to use adequate birth control for the duration of the study
• Participation in an investigational device or drug trial within the last 30 day
• Presence of any condition, abnormality or situation at Screening or at Baseline that in the opinion of the Principal Investigator may preclude the patient's ability to comply with study requirements, including completion of the study or the quality of the data

Where it is running

• St Mary's Eye Specialists, Inc. — San Francisco, California, United States
• Hunkeler Eye Institute — Overland Park, Kansas, United States
• The Johns Hopkins Hospital & Health System, Wilmer Eye Institute — Lutherville, Maryland, United States
• Harvard Medical School, Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States
• Charlotte Eye, Ear, Nose, and Throat Associates — Charlotte, North Carolina, United States
• University of Utah, John Moran Eye Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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