Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorReGenTree, LLC

About 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)

Eligibility criteria

Qualifiers

Be male or female of any race, at least 18 years of age;

Have provided written informed consent;

Be able and willing to follow instructions, including participation in all study assessments and visits;

At the time of Visit 1, have documentation or observation of a Persistent Epithelial Defect (PED) in one or both eyes, defined as a corneal epithelial defect that has not resolved after 1 week of conventional treatment using non-preserved ocular lubricants, non-preserved topical ophthalmic antibiotics, oral doxycycline, patching, amniotic membrane, serum tears, and/or therapeutic contact lenses;

Disqualifiers

Have any condition that, in the opinion of the Investigator, would interfere with the subject's ability to complete the study, would interfere with the interpretation of safety or efficacy, or would present an undue risk to the subject.

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

Clinically significant active blepharitis, meibomian gland dysfunction (MGD), or lid margin inflammation, or active ocular allergy in study eye that requires treatment that in the opinion of the investigator may interfere with the study parameters;

Have a Unanesthetized Schirmer's test score of ≤3 mm at Visit 1;

Trial design

Treatments tested in this trial

  • RGN-259
  • Placebo

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators