RGN-259 for Neurotrophic Keratopathy

Recruiting in Palo Alto (17 mi)

+36 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: ReGenTree, LLC

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Eligibility Criteria

Adults with stage 2 or 3 neurotrophic keratopathy (NK) in one eye, confirmed not to be just superficial damage. They must have reduced corneal sensitivity and a specific level of vision impairment. Participants need to agree to contraception use and can't have lid abnormalities, active infections/inflammation unrelated to NK, recent ocular surgery, or conditions that might affect the study's outcome.

Inclusion Criteria

Have provided written informed consent

I agree to use effective birth control.

I am 18 years old or older.

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Exclusion Criteria

Have any clinically significant slit-lamp findings in the study eye that in the opinion of the investigator may interfere with the study parameters

I do not have an autoimmune or chronic inflammatory disease that could affect the study treatment.

I plan to use serum tears in my study eye.

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Treatment Details

Interventions

Placebo (Other)
RGN-259 (Other)

Trial OverviewThe trial is testing RGN-259 ophthalmic solution against a placebo for treating NK. The goal is to see if RGN-259 is safe and works better than a placebo in healing the eye condition.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 0.1% RGN-259 Opthalmic SolutionExperimental Treatment1 Intervention

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

Group II: Placebo Ophthalmic Solution (Vehicle for RGN-259 Ophthalmic Solution)Placebo Group1 Intervention

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