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

PHASE3RecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

April 11, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

February 28, 2026

Conditions
Neurotrophic Keratopathy
Interventions
DRUG

RGN-259

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

DRUG

Placebo

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

Trial Locations (32)

10467

NOT_YET_RECRUITING

Montefiore Medical Center, The Bronx

15213

RECRUITING

UPMC Eye Center, Pittsburgh

27617

RECRUITING

Oculus Research, Raleigh

27710

RECRUITING

Duke Eye Center, Durham

28150

RECRUITING

CORE, Inc. / Vita Eye Clinic, Shelby

30328

RECRUITING

Thomas Eye Group, P.C., Sandy Springs

33136

RECRUITING

University of Miami - Bascom Palmer Eye Institute, Miami, Miami

33612

RECRUITING

University of South Florida, Ophthalmolgoy, Tampa

37232

TERMINATED

Vanderbilt Eye Institute, Nashville

40509

TERMINATED

Huffman & Huffman, PSC, Lexington

44106

RECRUITING

University Hospitals Cleveland Medical Center, Cleveland

44195

RECRUITING

Cleveland Clinic, Cole Eye Institute, Cleveland

46290

RECRUITING

Midwest Cornea Associates, LLC., Carmel

57701

TERMINATED

Black Hills Regional Eye Institute, Rapid City

60169

TERMINATED

Chicago Cornea Consultants, Hoffman Estates

60611

RECRUITING

Northwestern, Chicago

63108

RECRUITING

Washington University Eye Center, St Louis

75231

TERMINATED

Cornea Associates of Texas, Dallas

77025

TERMINATED

Houston Eye Associates, Houston

77478

RECRUITING

Berkeley Eye Center, Sugar Land

78240

RECRUITING

MCOA Eye Care, San Antonio

80503

RECRUITING

Advance Vision Research Institute, Longmont

80909

RECRUITING

Retina Consultants of Southern Colorado, Colorado Springs

92354

RECRUITING

Loma Linda University Eye Institute, Loma Linda

92653

RECRUITING

Harvard Eye Associates, Laguna Hills

97239

RECRUITING

OHSU Casey Eye Institute, Portland

97401

RECRUITING

Pacific ClearVision Institute, Eugene

98104

RECRUITING

University of Washington, Department of Ophthalmology, Seatle

06810

RECRUITING

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

02111

TERMINATED

Tufts Medical Center, Department of Ophthalmology, Boston

07724

TERMINATED

Atlantic Eye, Eatontown

07650

RECRUITING

Metropolitan Eye Research and Surgery Institute, Palisades Park

All Listed Sponsors
lead

ReGenTree, LLC

INDUSTRY