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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Neurotrophic Keratopathy

In brief

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.

Key facts

Study ID

NCT02600429

Run by

ReGenTree, LLC

People needed

18

Starts

2015-09-17

Expected to finish

2020-03-09

Last updated by the study team

2023-08-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be male or female of any race, at least 18 years of age
• Have provided verbal and written informed consent.
• Be able and willing to follow instructions, including participation in all study assessments and visits;
• Have stage 2 or 3 neurotrophic keratopathy in at least one eye If a female of childbearing potential, have a negative urine pregnancy test at Visit 1 and agree to use an adequate method of birth control throughout the study period.

You may not qualify if…

• Have any clinically significant slit lamp findings at Visit 1 that in the opinion of the investigator may interfere with the study parameters;
• Have significant blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergy that requires treatment
• Have a lid function abnormality (ex. Lagophthalmos) which, in the opinion of the investigator, is the primary cause of the persistent epithelial defect;
• Be diagnosed with ongoing ocular infection (bacterial, viral or fungal) or active inflammation (e.g. follicular conjunctivitis) not related to NK
• Anticipate the use of fluoroquinolone-containing antibiotic eye drops during the study;
• Have used contact lenses (excluding therapeutic contact lenses) within 14 days prior to Visit 1 or anticipates use of contact lenses during the study period;
• Have an uncontrolled systemic disease that in the opinion of the investigator may interfere with the study parameters;
• Anticipate a change in immunosuppressive therapy during the course of the study;

Where it is running

• Hull Eye Center — Lancaster, California, United States
• Vision Institute — Colorado Springs, Colorado, United States
• Eye Center of Northern Colorado — Fort Collins, Colorado, United States
• Insight Vision Group — Parker, Colorado, United States
• Medical Faculty Associates, Inc. — Washington D.C., District of Columbia, United States
• Midwest Cornea Associates, LLC — Indianapolis, Indiana, United States
• Koffler Vision Group — Lexington, Kentucky, United States
• Richard Eiferman, MD, PSC — Louisville, Kentucky, United States
• The Eye Care Institute — Louisville, Kentucky, United States
• Central Maine Eye Care — Lewiston, Maine, United States
• Black Hills Regional Eye Institute — Rapid City, South Dakota, United States

Full record on ClinicalTrials.gov

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