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SEER-2

Title 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) 
Therapeutic Area Keratitis
Principal Investigator Pedram Hamrah, MD
Min Age 18 Years
Gender Any
Contact Karaghan Curran
617-636-1051
neecresearch@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT05555589

Overview

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    

Study Details

Inclusion Criteria

1. 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 2. Have stage 2 or 3 neurotrophic keratopathy in at least one eye 3. Have evidence of decreased corneal sensitivity within the eye of the PED  

Exclusion Criteria

1.) Have a previous eye infection or be currently diagnosed with ongoing ocular infection (bacterial, viral or fungal) 2. History of any ocular surgery within the three months before study enrollment 3. 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.