SEER-2 (Neurotrophic Keratopathy)

Purpose of this Study

We are doing this study to find out if an investigational drug called RGN-259 Thymosin Beta 4 eye drops solution (the study drug) is a safe and effective option for the treatment of neurotrophic keratopathy.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Have persistent epithelial defect in one or both eyes
  • Are diagnosed with neurotrophic keratopathy
  • Have not had any eye surgery for the last 3 months
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.

What is Involved?

Description

If you choose to join the study, you will:
  • Get a random assignment (like a coin flip) to receive either the study drug or a placebo (sterile saline solution)
  • Visit our clinic at the Duke Eye Center up to 7 times
  • Keep in touch with the study team for up to 6 weeks
During the study visits, you will have eye exams and vision tests, and you will answer some questionnaires.

Study Details

Full Title

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) - RGN-NK-302

Principal Investigator

Lloyd
Williams

Protocol Number

PRO00113615

NCT ID

NCT05555589

Phase

III

Enrollment Status

Open to Enrollment
ClinicalTrials.gov