Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2
- Registration Number
- NCT05555589
- Lead Sponsor
- ReGenTree, LLC
- Brief Summary
The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Ophthalmic Solution (Vehicle for RGN-259 Ophthalmic Solution) Placebo It is composed of the same excipients as RGN-259 but does not contain Tβ4 0.1% RGN-259 Opthalmic Solution RGN-259 It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into study eye(s), five times per day for 28 days
- Primary Outcome Measures
Name Time Method Percentage of subjects achieving complete healing of PED at Day 29 Day 29 Percentage of subjects achieving complete healing of the Persistent Epithelial Defect (PED) at Day 29 determined by corneal fluorescein staining as measured by the Central Reading Center.
- Secondary Outcome Measures
Name Time Method Visual Acuity determined by ETDRS Day 8, 15, 22, 29, 36, and 43 Visual Acuity determined by Early Treatment of Diabetic Retinopathy Study (ETDRS)
NK stage by Mackie classification Day 8, 15, 22, 29, 36, and 43 NK stage graded according to the Mackie classification (Stage I, II, III. Higher scores mean a better or worse outcome)
Corneal sensitivity inside the lesion determined by Cochet Bonnet aesthesiometer (Unit: mm) Day 8, 15, 22, 29, 36, and 43 Percentage of subjects achieving complete healing of PED at Day 29 Day 29 Percentage of subjects achieving complete healing of the PED determined by corneal fluorescein staining as measured by the Investigator.
Percentage change from baseline of lesion size Day 8, 15, 22, 29, 36, and 43 Percentage change from baseline of lesion size determined by corneal fluorescein staining (measurements of greatest dimension of fluorescein staining)
Trial Locations
- Locations (33)
Advance Vision Research Institute
🇺🇸Longmont, Colorado, United States
Washington University Eye Center
🇺🇸Saint Louis, Missouri, United States
Connecticut Eye Consultants, P.C. Danbury Eye Physicians & Surgeons
🇺🇸Danbury, Connecticut, United States
University of Miami
🇺🇸Coral Gables, Florida, United States
Nvision Clinical Research, LLC.
🇺🇸Los Angeles, California, United States
Tufts Medical Center, Department of Ophthalmology
🇺🇸Boston, Massachusetts, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic, Cole Eye Institute
🇺🇸Cleveland, Ohio, United States
UPMC Eye Center
🇺🇸Pittsburgh, Pennsylvania, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
University of Washington, Department of Ophthalmology
🇺🇸Seattle, Washington, United States
Northwestern
🇺🇸Chicago, Illinois, United States
Duke Eye Center
🇺🇸Durham, North Carolina, United States
MCOA Eye Care
🇺🇸San Antonio, Texas, United States
Vanderbilt Eye Institute
🇺🇸Nashville, Tennessee, United States
Harvard Eye Associates
🇺🇸Laguna Hills, California, United States
Loma Linda University Eye Institute
🇺🇸Loma Linda, California, United States
Dr. Shultz and Dr. Chan
🇺🇸Northridge, California, United States
Thomas Eye Group, P.C.
🇺🇸Sandy Springs, Georgia, United States
University of South Florida, Ophthalmolgoy
🇺🇸Tampa, Florida, United States
Chicago Cornea Consultants
🇺🇸Hoffman Estates, Illinois, United States
Midwest Cornea Associates, LLC.
🇺🇸Carmel, Indiana, United States
Huffman & Huffman, PSC
🇺🇸Lexington, Kentucky, United States
Metropolitan Eye Research and Surgery Institute
🇺🇸Palisades Park, New Jersey, United States
Atlantic Eye
🇺🇸Eatontown, New Jersey, United States
Oculus Research
🇺🇸Raleigh, North Carolina, United States
CORE, Inc. / Vita Eye Clinic
🇺🇸Shelby, North Carolina, United States
Pacific ClearVision Institute
🇺🇸Eugene, Oregon, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
OHSU Casey Eye Institute
🇺🇸Portland, Oregon, United States
Cornea Associates of Texas
🇺🇸Dallas, Texas, United States
Retina Consultants of Southern Colorado
🇺🇸Colorado Springs, Colorado, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States