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 | Completed Phase 1

• 1 other identifier: CK-0103
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Contrast Sensitivity

Outcome Measures

Primary Outcomes (1)

• Contrast Sensitivity (Mesopic) Responder Analysis

  Proportion of patients with ≥ 2-patch (0.30 logCS) contrast sensitivity improvement in at least two spatial frequencies under mesopic illumination

  Baseline, Days 30, 60, 90, and 120

Secondary Outcomes (1)

• Cumulative Improvement in Contrast Sensitivity (Mesopic)

  Baseline, Days 30, 60, 90, and 120

Other Outcomes (3)

• Mean Change in Contrast Sensitivity (Mesopic)

  Baseline, Days 30, 60, 90, and 120

• Mean Change in Best-Corrected Visual Acuity (BCVA)

  Baseline, Days 30, 60, 90, and 120

• Pentacam Imaging

  Baseline, Baseline, Days 120

Study Arms (3)

C-KAD 2.6%

EXPERIMENTAL

Administered four times a day (QID; no less than 3 hours apart) in both eyes for 120 days

Drug: EDTA Ophthalmic Solution 2.6%

C-KAD 1.3%

EXPERIMENTAL

Administered four times a day (QID; no less than 3 hours apart) in both eyes for 120 days

Drug: EDTA Ophthalmic Solution 1.3%

Placebo

PLACEBO COMPARATOR

Administered four times a day (QID; no less than 3 hours apart) in both eyes for 120 days

Drug: Saline Solution (Placebo)

Interventions

EDTA Ophthalmic Solution 2.6% DRUG

Also known as: C-KAD 2.6%

C-KAD 2.6%

EDTA Ophthalmic Solution 1.3% DRUG

Also known as: C-KAD 1.3%

C-KAD 1.3%

Saline Solution (Placebo) DRUG

Also known as: Software Saline

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Livionex Inc.: lead

Study Sites (6)

St Mary's Eye Specialists, Inc.

San Francisco, California, 94117, United States

Location

Hunkeler Eye Institute

Overland Park, Kansas, 66210, United States

Location

The Johns Hopkins Hospital & Health System, Wilmer Eye Institute

Lutherville, Maryland, 21093, United States

Location

Harvard Medical School, Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Charlotte Eye, Ear, Nose, and Throat Associates

Charlotte, North Carolina, 28210, United States

Location

University of Utah, John Moran Eye Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: January 1, 2006
• Primary Completion: December 31, 2006
• Study Completion: April 30, 2007
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)