RGN-259 Clinical Trials (2026): 5 Studies for Dry Eye Syndrome & Neurotrophic Keratopathy
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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5 RGN-259 clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 3 indications (including Dry Eye Syndrome & Neurotrophic Keratopathy) and 1,706 total planned enrollment. 4 Phase 3 RGN-259 trials are listed. 1 RGN-259 clinical trial is actively recruiting at 24 U.S. sites across 17 states. Most recent activity: NCT05555589 (May 2026).
Where to Participate: All RGN-259 Trial Sites in the U.S. (24 sites across 17 states)
Every actively recruiting RGN-259trial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| CA | Harvard Eye Associates | Laguna Hills92653 | NCT05555589 | Map |
| CA | Loma Linda University Eye Institute | Loma Linda92354 | NCT05555589 | Map |
| CO | Advance Vision Research Institute | Longmont80503 | NCT05555589 | Map |
| CT | Connecticut Eye Consultants, P.C. Danbury Eye Physicians & Surgeons | Danbury06810 | NCT05555589 | Map |
| FL | Nature Coast Clinical Research | Crystal River34429 | NCT05555589 | Map |
| FL | University of Miami - Bascom Palmer Eye Institute, Miami | Miami33136 | NCT05555589 | Map |
| FL | University of South Florida, Ophthalmolgoy | Tampa33612 | NCT05555589 | Map |
| GA | Thomas Eye Group, P.C. | Sandy Springs30328 | NCT05555589 | Map |
| IL | Northwestern | Chicago60611 | NCT05555589 | Map |
| IN | Midwest Cornea Associates, LLC. | Carmel46290 | NCT05555589 | Map |
| MO | Midwest Vision Research Foundation | Chesterfield63017 | NCT05555589 | Map |
| MO | Washington University Eye Center | St Louis63108 | NCT05555589 | Map |
| NJ | Metropolitan Eye Research and Surgery Institute | Palisades Park07650 | NCT05555589 | Map |
| NY | Montefiore Medical Center | The Bronx10467 | NCT05555589 | Map |
| NC | Duke Eye Center | Durham27710 | NCT05555589 | Map |
| OH | Cleveland Clinic, Cole Eye Institute | Cleveland44195 | NCT05555589 | Map |
| OH | University Hospitals Cleveland Medical Center | Cleveland44106 | NCT05555589 | Map |
| OR | Cataract & Laser Institute of Southern Oregon | Medford97504 | NCT05555589 | Map |
| OR | OHSU Casey Eye Institute | Portland97239 | NCT05555589 | Map |
| PA | UPMC Eye Center | Pittsburgh15213 | NCT05555589 | Map |
| TX | MCOA Eye Care | San Antonio78240 | NCT05555589 | Map |
| TX | Berkeley Eye Center | Sugar Land77478 | NCT05555589 | Map |
| VA | Virginia Eye Consultants | Norfolk23502 | NCT05555589 | Map |
| WA | University of Washington, Department of Ophthalmology | Seatle98104 | NCT05555589 | — |
RGN-259 clinical trials at a glance: phase × recruitment status
| Phase | recruiting | completed | terminated | Total |
|---|---|---|---|---|
| P2/P3 | 1 | 1 | ||
| P3 | 1 | 2 | 1 | 4 |
Recruiting RGN-259 clinical trials (1)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT05555589 | Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2 | P3 | Neurotrophic Keratopathy | 70 | Apr 2023 |
RGN-259 clinical trials by indication
Neurotrophic Keratopathy (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05555589 | — | P3 | recruiting | Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2 |
| NCT02600429 | — | P3 | terminated | Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1 |
Dry Eye Syndrome (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02974907 | — | P3 | completed | Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2 |
| NCT02597803 | — | P2/P3 | completed | Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1 |
Dry Eye Syndromes (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03937882 | ARISE-3 | P3 | completed | Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3 |
RGN-259 pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| ARISE-3 | NCT03937882 | P3 | completed | Dry Eye Syndromes | 700 | — |
Terminated and withdrawn RGN-259 trials (1)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT02600429terminatedAssessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1
All RGN-259 trials (5)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT05555589 | Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2 | P3 | recruiting | 70 | ReGenTree, LLC | Apr 2023 | |
| NCT03937882 | ARISE-3 | Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3 | P3 | completed | 700 | ReGenTree, LLC | May 2019 |
| NCT02600429 | Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1 | P3 | terminated | 18 | ReGenTree, LLC | Sep 2015 | |
| NCT02974907 | Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2 | P3 | completed | 601 | ReGenTree, LLC | Nov 2016 | |
| NCT02597803 | Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1 | P2/P3 | completed | 317 | ReGenTree, LLC | Sep 2015 |
RGN-259 clinical trials: frequently asked questions
- How many RGN-259 clinical trials are there?
- 5 RGN-259 clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 1 is actively recruiting participants. 3 are marked completed.
- Are RGN-259 clinical trials recruiting in 2026?
- Yes — 1 RGN-259 trial is actively recruiting in 2026, with 24 U.S. sites across 17 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is RGN-259 being studied for?
- RGN-259 is being studied for Dry Eye Syndrome, Neurotrophic Keratopathy, Dry Eye, Dry Eye Syndromes. The trials are grouped by indication on this page.
- What phase is RGN-259 in?
- RGN-259 clinical trials span 4 Phase 3. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors RGN-259 clinical trials?
- The lead sponsor across the most RGN-259 trials is ReGenTree, LLC. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming RGN-259as an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
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