The objective of this study is to assess the safety and efficacy of RGN-259 Ophthalmic Solution compared to placebo for the treatment of NK.
Neurotrophic keratopathy (NK) is a degenerative corneal disease that occurs as a result of partial or total impairment of trigeminal innervation. The resulting loss of corneal sensitivity (anesthesia) leads to a reduction in lacrimation and a decline in status, metabolism, and mitosis of corneal epithelial cells. Previous studies (physician-sponsored studies) used to treat to nine patients with NK, six of whom had discrete geographic, non-healing lesions, and three of whom had punctate lesions and the study result reported.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
18
Hull Eye Center
Lancaster, California, United States
Vision Institute
Colorado Springs, Colorado, United States
Eye Center of Northern Colorado
Fort Collins, Colorado, United States
Percentage of Subjects Achieving Complete Healing at Day 29.
Percentage of subjects achieving complete healing of the persistent epithelial defect as determined by corneal fluorescein staining at day 29 after first dosing.
Time frame: 29 days after first dosing
Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days
Percentage of subjects achieving complete healing of the Persistent Epithelial Defect(PED) determined by corneal fluorescein staining at 8, 15, 22, 36, 43 days after first dosing.
Time frame: 8, 15, 22, 36, 43 days after first dosing
Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification.
Epithelial Defect Measurement and Classification as stage 1, 2 or 3 using Mackie Classification at 8, 15, 22, 29, 36, 43 days after first dosing
Time frame: 8, 15, 22, 29, 36, 43 days after first dosing
Tear Film Break-up Time at 29, 36, 43 Days
Tear Film Break-up Time at 29, 36, 43 days after first dosing
Time frame: 29, 36, 43 days after first dosing
Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing
Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing at Visits 2, 3, 4, 5, 6, and 7 (The scale used to determine the difference in Ocular Discomfort by questionnaire on each visit is from 0(None) to 5(Most). This outcome was calculated from two time points as the value at the later time point minus the value at the first dosing points and the lower value are considered to be a better outcome. and the all relevant time points used in the calculation in the Time Frame was 8, 15, 22, 29, 36, 43 days.)
Time frame: 8, 15, 22, 29, 36, 43 days after first dosing
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Insight Vision Group
Parker, Colorado, United States
Medical Faculty Associates, Inc.
Washington D.C., District of Columbia, United States
Midwest Cornea Associates, LLC
Indianapolis, Indiana, United States
Koffler Vision Group
Lexington, Kentucky, United States
Richard Eiferman, MD, PSC
Louisville, Kentucky, United States
The Eye Care Institute
Louisville, Kentucky, United States
Central Maine Eye Care
Lewiston, Maine, United States
...and 1 more locations
Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days
Visual acuity(logMAR) at 8, 15, 22, 29, 36, 43 days (The Visual acuity was assessed by LogMAR calculation method. In the case of the LogMAR method, Each letter has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units. and The lower value are considered to be a better outcome.) The formula used in calculating the score is: LogMAR VA = 0.1 + LogMAR value of the best line read - 0.02 X (number of optotypes read) used to determine the difference in Ocular Discomfort by questionnaire on each visit is the ORA scale: 0 None to 5: Most And as this outcome was calculated from two time points as the value at the later time point minus the value at the first dosing points, The lower value are considered to be a better outcome. and the all relevant time points used in the calculation in the Time Frame was 8, 15, 22, 29, 36, 43 days.)
Time frame: 8, 15, 22, 29, 36, 43 days after first dosing