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Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1 | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

Phase 3, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of RGN-259 Ophthalmic Solution for the Treatment of Neurotrophic Keratopathy: SEER-1

NCT02600429•ReGenTree, LLC

View on ClinicalTrials.gov

Summary

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.

Detailed Description

Neurotrophic keratopathy (NK) is a degenerative corneal disease that occurs as a result of partial or total impairment of trigeminal innervation. The resulting loss of corneal sensitivity (anesthesia) leads to a reduction in lacrimation and a decline in status, metabolism, and mitosis of corneal epithelial cells. Previous studies (physician-sponsored studies) used to treat to nine patients with NK, six of whom had discrete geographic, non-healing lesions, and three of whom had punctate lesions and the study result reported.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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;

Locations (11)

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

Key Dates

Start Date

September 17, 2015

Primary Completion Date

November 20, 2019

Completion Date

March 9, 2020

Last Updated

August 30, 2023

Enrollment

ACTUAL participants

Conditions

Neurotrophic Keratopathy

Interventions

RGN-259

DRUG

Placebo

DRUG

Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis

NCT06411145

Neurotrophic KeratitisNeurotrophic Keratopathy+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 30, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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