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:<ul>
<li>Have persistent epithelial defect in one or both eyes</li>
<li>Are diagnosed with neurotrophic keratopathy</li>
<li>Have not had any eye surgery for the last 3 months</li></ul>
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.
<li>Have persistent epithelial defect in one or both eyes</li>
<li>Are diagnosed with neurotrophic keratopathy</li>
<li>Have not had any eye surgery for the last 3 months</li></ul>
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.
What is Involved?
If you choose to join the study, you will:<ul>
<li>Get a random assignment (like a coin flip) to receive either the study drug or a placebo (sterile saline solution)</li>
<li>Visit our clinic at the Duke Eye Center up to 7 times</li>
<li>Keep in touch with the study team for up to 6 weeks</li></ul>
During the study visits, you will have eye exams and vision tests, and you will answer some questionnaires.
<li>Get a random assignment (like a coin flip) to receive either the study drug or a placebo (sterile saline solution)</li>
<li>Visit our clinic at the Duke Eye Center up to 7 times</li>
<li>Keep in touch with the study team for up to 6 weeks</li></ul>
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