Actively Recruiting
Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2
Led by ReGenTree, LLC · Updated on 2025-12-23
70
Participants Needed
36
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)
CONDITIONS
Official Title
Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be male or female of any race, aged 18 years or older
- Provide written informed consent
- Be able and willing to follow all study instructions and attend all visits
- Have a persistent corneal epithelial defect (PED) not healed after at least 1 week of conventional treatment
- Have stage 2 or 3 neurotrophic keratopathy in at least one eye with a defect measuring at least 1 mm
- Show decreased corneal sensitivity of 40 mm or less using the Cochet-Bonnet aesthesiometer
- Have a best corrected visual acuity score of 75 letters or more in the study eye
- Female participants of child-bearing potential must be non-lactating, use acceptable contraception before and after dosing, and have a negative pregnancy test
- Male participants must agree to use effective contraception
You will not qualify if you...
- Any condition that may interfere with study completion, safety, or data interpretation
- Significant slit-lamp findings in the study eye that affect study parameters
- Active blepharitis, meibomian gland dysfunction, lid margin inflammation, or ocular allergy requiring treatment in the study eye
- Unanesthetized Schirmer's test score of 3 mm or less
- Lid function abnormalities causing the corneal defect
- Ongoing ocular infection or active inflammation in the study eye
- History of ocular surgery within 3 months prior to enrollment
- Prior surgical treatment for NK within 3 months, except amniotic membrane transplantation
- Planned ocular surgery during the study
- Botox injection for blepharoptosis in study eye within 90 days
- Contact lens use in study eye within 14 days or anticipated during study
- Use of Oxervate in study eye within past 2 months
- Anticipated use of serum tears during study
- Any ocular or systemic disorder affecting treatment efficacy or study conduct
- Use of drugs affecting lacrimation or trigeminal nerve function within 30 days or anticipated during study
- Autoimmune or chronic inflammatory diseases
- Use of topical ocular or nasal immunosuppressive therapy within 30 days or anticipated
- Known allergy or sensitivity to study product
- History of drug, medication, or alcohol abuse
- Participation in investigational drug study within 30 days
- Fever, systemic illness, or positive COVID-19 test within 2 weeks before dosing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 36 locations
1
Harvard Eye Associates
Laguna Hills, California, United States, 92653
Actively Recruiting
2
Loma Linda University Eye Institute
Loma Linda, California, United States, 92354
Actively Recruiting
3
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, United States, 80909
Active, Not Recruiting
4
Advance Vision Research Institute
Longmont, Colorado, United States, 80503
Actively Recruiting
5
Connecticut Eye Consultants, P.C. Danbury Eye Physicians & Surgeons
Danbury, Connecticut, United States, 06810
Actively Recruiting
6
Nature Coast Clinical Research
Crystal River, Florida, United States, 34429
Actively Recruiting
7
University of Miami - Bascom Palmer Eye Institute, Miami
Miami, Florida, United States, 33136
Actively Recruiting
8
University of South Florida, Ophthalmolgoy
Tampa, Florida, United States, 33612
Actively Recruiting
9
Thomas Eye Group, P.C.
Sandy Springs, Georgia, United States, 30328
Actively Recruiting
10
Northwestern
Chicago, Illinois, United States, 60611
Actively Recruiting
11
Midwest Cornea Associates, LLC.
Carmel, Indiana, United States, 46290
Actively Recruiting
12
Huffman & Huffman, PSC
Lexington, Kentucky, United States, 40509
Active, Not Recruiting
13
Midwest Vision Research Foundation
Chesterfield, Missouri, United States, 63017
Actively Recruiting
14
Washington University Eye Center
St Louis, Missouri, United States, 63108
Actively Recruiting
15
Metropolitan Eye Research and Surgery Institute
Palisades Park, New Jersey, United States, 07650
Actively Recruiting
16
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
17
Duke Eye Center
Durham, North Carolina, United States, 27710
Actively Recruiting
18
Oculus Research
Raleigh, North Carolina, United States, 27617
Active, Not Recruiting
19
CORE, Inc. / Vita Eye Clinic
Shelby, North Carolina, United States, 28150
Active, Not Recruiting
20
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
21
Cleveland Clinic, Cole Eye Institute
Cleveland, Ohio, United States, 44195
Actively Recruiting
22
Pacific ClearVision Institute
Eugene, Oregon, United States, 97401
Active, Not Recruiting
23
Cataract & Laser Institute of Southern Oregon
Medford, Oregon, United States, 97504
Actively Recruiting
24
OHSU Casey Eye Institute
Portland, Oregon, United States, 97239
Actively Recruiting
25
UPMC Eye Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
26
MCOA Eye Care
San Antonio, Texas, United States, 78240
Actively Recruiting
27
Berkeley Eye Center
Sugar Land, Texas, United States, 77478
Actively Recruiting
28
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Actively Recruiting
29
University of Washington, Department of Ophthalmology
Seatle, Washington, United States, 98104
Actively Recruiting
30
Università di Brescia
Brescia, Brescia, Italy, 25123
Actively Recruiting
31
Azienda Ospedaliero Universitaria Careggi
Florence, Firenze, Italy, 50134
Actively Recruiting
32
Gabinet Okulistyczny Prof Edward Wylegala
Katowice, Silesian Voivodeship, Poland, 40-594
Actively Recruiting
33
IMO Barcelona, Grupo Miranza
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
34
Hospital La Arruzafa
Córdoba, Córdoba, Spain, 14012
Actively Recruiting
35
Instituto Oftalmológico Fernández-Vega
Oviedo, Principality of Asturias, Spain, 33012
Actively Recruiting
36
Aiken Prevención & Cirugía Ocular
Valencia, Valencia, Spain, 46004
Actively Recruiting
Research Team
R
ReGenTree, LLC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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