Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1

Part of paid clinical trials in Lancaster, California.

Sponsor
ReGenTree, LLC
Study ID
NCT02600429
Phase
PHASE3
Status
Terminated

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 affected eye(s), five times a day for 4 weeks.
  • Placebo — DRUG
    It is composed of the same excipients as RGN-259 but does not contain Tβ4

Study Details

The objective of this study is to assess the safety and efficacy of RGN-259 Ophthalmic Solution compared to placebo for the treatment of NK.

Key Dates

Start date
Sep 17, 2015
Status verified
Jul 2023
Primary completion
Nov 20, 2019
Completion
Mar 9, 2020

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RGN-259
    It is a preservative-free, sterile eye drop solution containing Tβ4
  • Placebo Comparator: Placebo
    It is composed of the same excipients as RGN-259 but does not contain Tβ4.

Primary Outcome Measure

Percentage of Subjects Achieving Complete Healing at Day 29. [ Time Frame: 29 days after first dosing ]

Locations (11)

FacilityCityStateZIPSite coordinators
Hull Eye CenterLancasterCalifornia93534-
Vision InstituteColorado SpringsColorado80907-
Eye Center of Northern ColoradoFort CollinsColorado80525-
Insight Vision GroupParkerColorado80134-
Medical Faculty Associates, Inc.Washington D.C.District of Columbia20037-
Midwest Cornea Associates, LLCIndianapolisIndiana46290-
Koffler Vision GroupLexingtonKentucky40509-
Richard Eiferman, MD, PSCLouisvilleKentucky40205-
The Eye Care InstituteLouisvilleKentucky40206-
Central Maine Eye CareLewistonMaine04240-
Black Hills Regional Eye InstituteRapid CitySouth Dakota57701-

Find similar trials in Lancaster, CA

By research site
Hull Eye Center· Lancaster, CAVision Institute· Colorado Springs, COEye Center of Northern Colorado· Fort Collins, COInsight Vision Group· Parker, COMedical Faculty Associates, Inc.· Washington D.C., DCMidwest Cornea Associates, LLC· Indianapolis, IN

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