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NCT05555589 · ClinicalTrials.gov registry record · Phase 3
Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2
A Phase 3 study of Neurotrophic Keratopathy, sponsored by ReGenTree.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 70
- Enrollment target
- 20
- Study locations
NCT05555589: Recruiting Phase 3 study of Neurotrophic Keratopathy, sponsored by ReGenTree.
NCT05555589 is a Phase 3 study of Neurotrophic Keratopathy that is actively recruiting participants, run by ReGenTree. The registered enrollment target is 70 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05555589, a Phase 3 study of Neurotrophic Keratopathy, is actively recruiting participants, sponsored by ReGenTree.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 70 participants
- Enrollment target
- 20
- Study locations
Study 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)
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG RGN-259
Study Locations (20)
Florida
- Nature Coast Clinical Research - Crystal River
- University of Miami - Bascom Palmer Eye Institute, Miami - Miami
- University of South Florida, Ophthalmolgoy - Tampa
North Carolina
- Duke Eye Center - Durham
- Oculus Research - Raleigh
- CORE, Inc. / Vita Eye Clinic - Shelby
California
- Harvard Eye Associates - Laguna Hills
- Loma Linda University Eye Institute - Loma Linda
Colorado
- Retina Consultants of Southern Colorado - Colorado Springs
- Advance Vision Research Institute - Longmont
Missouri
- Midwest Vision Research Foundation - Chesterfield
- Washington University Eye Center - St Louis
Connecticut
- Connecticut Eye Consultants, P.C. Danbury Eye Physicians & Surgeons - Danbury
Georgia
- Thomas Eye Group, P.C. - Sandy Springs
Illinois
- Northwestern - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2023-04-11 |
| Est. Completion | 2026-05-30 |
| Phase | Phase 3 |
What NCT05555589 shows while recruiting
NCT05555589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Neurotrophic Keratopathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05555589 names 20 study sites across 13 states, led by Florida, North Carolina, California.
Frequently Asked Questions
What is clinical trial NCT05555589 about?
NCT05555589 is a clinical study titled "Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2". The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)
What is the current status of trial NCT05555589?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2023-04-11. Estimated completion is 2026-05-30.
What conditions does trial NCT05555589 study?
This clinical trial studies the following conditions: Neurotrophic Keratopathy.
What interventions are being tested in trial NCT05555589?
The interventions under investigation include: Placebo (DRUG), RGN-259 (DRUG).
Who is sponsoring clinical trial NCT05555589?
This trial is sponsored by ReGenTree, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05555589 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05555589's enrollment target sits among peer trials
70 1786th of 2000 higher than 208 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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