A Phase 1/2, Randomized, Placebo-Controlled, Double-Masked, Multicenter, Dose-Ranging, Safety and Efficacy of C-KAD Ophthalmic Solution in Patients With Loss of Contrast Sensitivity Due to Age-Related, Low-Grade Nuclear Cataract
Overview
- Phase
- Phase 1
- Intervention
- EDTA Ophthalmic Solution 2.6%
- Conditions
- Age Related Cataracts
- Sponsor
- Livionex Inc.
- Enrollment
- 111
- Locations
- 6
- Primary Endpoint
- Contrast Sensitivity (Mesopic) Responder Analysis
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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).
Detailed Description
This was a prospective, randomized, placebo-controlled, double-masked, parallel evaluation of the safety and efficacy of EDTA ophthalmic solution in patients with loss of contrast sensitivity due to age-related, low-grade cataract. 111 subjects were enrolled at six study sites within the U.S. and randomly assigned in 1:1:1 ratio to treatment with 2.6% C-KAD, 1.3% C-KAD and placebo. The treatment duration was 120 days with a run-in period and follow-up period of 14 days each. During the Run-in Period, patients received pre-treatment with lubricating eye drops (Refresh® Plus Lubricant Eye Drops) in both eyes to ensure uniformity in the level of ocular hydration at Baseline in patients randomized into the study. Patients were evaluated at a Screening Visit (Day -14), at Baseline (Day 0), during the dosing period (Days 30, 60, 90, 120) and at the Follow-up Visit (Day 134), two weeks after completion of active treatment. Tolerability and efficacy were assessed by Slit Lamp and Fundus Examinations, Best-Corrected Distance Visual Acuity, Contrast Sensitivity, Endothelial Cell Count, Pentacam Imaging, Tear Film Break-Up Time, IOP measurements, Pupil Size measurement and evaluation of Adverse Events.
Investigators
Eligibility Criteria
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
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 within the central 4mm of the lens
- •Presence or history of any ocular inflammatory disorder in either eye (e.g., uveitis, ocular allergies)
Arms & Interventions
C-KAD 2.6%
Administered four times a day (QID; no less than 3 hours apart) in both eyes for 120 days
Intervention: EDTA Ophthalmic Solution 2.6%
C-KAD 1.3%
Administered four times a day (QID; no less than 3 hours apart) in both eyes for 120 days
Intervention: EDTA Ophthalmic Solution 1.3%
Placebo
Administered four times a day (QID; no less than 3 hours apart) in both eyes for 120 days
Intervention: Saline Solution (Placebo)
Outcomes
Primary Outcomes
Contrast Sensitivity (Mesopic) Responder Analysis
Time Frame: Baseline, Days 30, 60, 90, and 120
Proportion of patients with ≥ 2-patch (0.30 logCS) contrast sensitivity improvement in at least two spatial frequencies under mesopic illumination
Secondary Outcomes
- Cumulative Improvement in Contrast Sensitivity (Mesopic)(Baseline, Days 30, 60, 90, and 120)