RGN-259 eye drops compared to placebo eye drops 5 times per day in both eyes for the treatment of Neurotrophic Keratopathy. Percentage of subjects achieving complete healing (defined as 0 mm lesion size) of the Persistent Epithelial Defect (PED) at Visit 5 (Day 29) determined by corneal fluorescein staining captured by corneal photography and analyzed by a central reading center
SEER-2
A Phase 3, Multi-Center, Randomized, Parallel, Double Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of Neurotrophic Keratopathy (SEER-2)
Neurotrophic keratitis
All genders
18+
Recruiting now
Overview
Principal Investigator: Pedram Hamrah, MD
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Nancy Gee
Study details
Inclusion Criteria
- Documentation of a Persistent Epithelial Defect (PED) in one or both eyes, defined as a corneal epithelial defect that has not resolved after 1 week of conventional, nonsurgical treatment
- Have stage 2 or 3 neurotrophic keratopathy in at least one eye
- Have evidence of decreased corneal sensitivity within the eye of the PED
Exclusion Criteria
- Have a previous fungal infection or be currently diagnosed with ongoing ocular infection (bacterial, viral or fungal)
- History of any ocular surgery within the three months before study enrollment
- Have of OxervateTM in the study eye within the past 2 months
Study Requirements
Adminsitration of study eye drops to both eyes, 5 times a day, for 28 days. Monitoring for 14 days following study eye drop completion for a total of seven visits to your study doctors office over six weeks. Corneal photography, measurement of corneal lesion size, and corneal sensitivity will be performed at each visit.