RecruitingPhase 3NCT05555589

Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2

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)


Sponsor

ReGenTree, LLC

Enrollment

70 participants

Start Date

Apr 11, 2023

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called RGN-259 for people with neurotrophic keratopathy. The study is currently recruiting participants at 36 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRGN-259

A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into study eye(s), five times per day for 28 days

DRUGPlacebo

It is composed of the same excipients as RGN-259 but does not contain Tβ4. Direct instillation into study eye(s), five times per day for 28 days


Locations(36)

Harvard Eye Associates

Laguna Hills, California, United States

Loma Linda University Eye Institute

Loma Linda, California, United States

Retina Consultants of Southern Colorado

Colorado Springs, Colorado, United States

Advance Vision Research Institute

Longmont, Colorado, United States

Connecticut Eye Consultants, P.C. Danbury Eye Physicians & Surgeons

Danbury, Connecticut, United States

Nature Coast Clinical Research

Crystal River, Florida, United States

University of Miami - Bascom Palmer Eye Institute, Miami

Miami, Florida, United States

University of South Florida, Ophthalmolgoy

Tampa, Florida, United States

Thomas Eye Group, P.C.

Sandy Springs, Georgia, United States

Northwestern

Chicago, Illinois, United States

Midwest Cornea Associates, LLC.

Carmel, Indiana, United States

Huffman & Huffman, PSC

Lexington, Kentucky, United States

Midwest Vision Research Foundation

Chesterfield, Missouri, United States

Washington University Eye Center

St Louis, Missouri, United States

Metropolitan Eye Research and Surgery Institute

Palisades Park, New Jersey, United States

Montefiore Medical Center

The Bronx, New York, United States

Duke Eye Center

Durham, North Carolina, United States

Oculus Research

Raleigh, North Carolina, United States

CORE, Inc. / Vita Eye Clinic

Shelby, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic, Cole Eye Institute

Cleveland, Ohio, United States

Pacific ClearVision Institute

Eugene, Oregon, United States

Cataract & Laser Institute of Southern Oregon

Medford, Oregon, United States

OHSU Casey Eye Institute

Portland, Oregon, United States

UPMC Eye Center

Pittsburgh, Pennsylvania, United States

MCOA Eye Care

San Antonio, Texas, United States

Berkeley Eye Center

Sugar Land, Texas, United States

Virginia Eye Consultants

Norfolk, Virginia, United States

University of Washington, Department of Ophthalmology

Seatle, Washington, United States

Università di Brescia

Brescia, Brescia, Italy

Azienda Ospedaliero Universitaria Careggi

Florence, Firenze, Italy

Gabinet Okulistyczny Prof Edward Wylegala

Katowice, Silesian Voivodeship, Poland

IMO Barcelona, Grupo Miranza

Barcelona, Barcelona, Spain

Hospital La Arruzafa

Córdoba, Córdoba, Spain

Instituto Oftalmológico Fernández-Vega

Oviedo, Principality of Asturias, Spain

Aiken Prevención & Cirugía Ocular

Valencia, Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT05555589


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