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

Part of paid clinical trials in Laguna Hills, California.

Sponsor
ReGenTree, LLC
Study ID
NCT05555589
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Neurotrophic Keratopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RGN-259 — DRUG
    A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into study eye(s), five times per day for 28 days
  • Placebo — DRUG
    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

Study Details

The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)

Key Dates

Start date
Apr 11, 2023
Status verified
Dec 2025
Primary completion
Apr 30, 2026
Completion
May 30, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 0.1% RGN-259 Opthalmic Solution
    It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into study eye(s), five times per day for 28 days
  • Placebo Comparator: Placebo Ophthalmic Solution (Vehicle for RGN-259 Ophthalmic Solution)
    It is composed of the same excipients as RGN-259 but does not contain Tβ4

Primary Outcome Measure

Percentage of subjects achieving complete healing of PED at Day 29 [ Time Frame: Day 29 ]

Central Contacts

Locations (29)

FacilityCityStateZIPSite coordinators
Harvard Eye AssociatesLaguna HillsCalifornia92653-
Loma Linda University Eye InstituteLoma LindaCalifornia92354-
Retina Consultants of Southern ColoradoColorado SpringsColorado80909-
Advance Vision Research InstituteLongmontColorado80503-
Connecticut Eye Consultants, P.C. Danbury Eye Physicians & SurgeonsDanburyConnecticut06810-
Nature Coast Clinical ResearchCrystal RiverFlorida34429-
University of Miami - Bascom Palmer Eye Institute, MiamiMiamiFlorida33136-
University of South Florida, OphthalmolgoyTampaFlorida33612-
Thomas Eye Group, P.C.Sandy SpringsGeorgia30328-
NorthwesternChicagoIllinois60611-
Midwest Cornea Associates, LLC.CarmelIndiana46290-
Huffman & Huffman, PSCLexingtonKentucky40509-
Midwest Vision Research FoundationChesterfieldMissouri63017-
Washington University Eye CenterSt LouisMissouri63108-
Metropolitan Eye Research and Surgery InstitutePalisades ParkNew Jersey07650-
Montefiore Medical CenterThe BronxNew York10467-
Duke Eye CenterDurhamNorth Carolina27710-
Oculus ResearchRaleighNorth Carolina27617-
CORE, Inc. / Vita Eye ClinicShelbyNorth Carolina28150-
Cleveland Clinic, Cole Eye InstituteClevelandOhio44195-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Pacific ClearVision InstituteEugeneOregon97401-
Cataract & Laser Institute of Southern OregonMedfordOregon97504-
OHSU Casey Eye InstitutePortlandOregon97239-
UPMC Eye CenterPittsburghPennsylvania15213-
MCOA Eye CareSan AntonioTexas78240-
Berkeley Eye CenterSugar LandTexas77478-
Virginia Eye ConsultantsNorfolkVirginia23502-
University of Washington, Department of OphthalmologySeatleWashington98104-

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By research site
Harvard Eye Associates· Laguna Hills, CALoma Linda University Eye Institute· Loma Linda, CARetina Consultants of Southern Colorado· Colorado Springs, COAdvance Vision Research Institute· Longmont, COConnecticut Eye Consultants, P.C. Danbury Eye Physicians & Surgeons· Danbury, CTNature Coast Clinical Research· Crystal River, FL