Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365762
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2024-04-10
Brief Title:
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
Sponsor:
Livionex Inc
Organization:
Livionex Inc
Study Overview
Official Title:
A Phase 12 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
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study objectives were
To evaluate the efficacy of EDTA 13 and 26 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 studys
To evaluate the efficacy of EDTA 13 and 26 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 studys
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 US and randomly assigned in 111 ratio to treatment with 26 C-KAD 13 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
111 subjects were enrolled at six study sites within the US and randomly assigned in 111 ratio to treatment with 26 C-KAD 13 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None