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

NCT02600429 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-08-30

Study results available
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Summary

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.

Conditions

  • Neurotrophic Keratopathy

Interventions

DRUG

RGN-259

A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into affected eye(s), five times a day for 4 weeks.

DRUG

Placebo

It is composed of the same excipients as RGN-259 but does not contain Tβ4

Sponsors & Collaborators

  • ReGenTree, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-17
Primary Completion
2019-11-20
Completion
2020-03-09

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02600429 on ClinicalTrials.gov