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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:September 2015
End Date:August 2019
Contact:Shinwook Kang
Email:swkang@regentreellc.com
Phone:609-649-5505

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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

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.

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.

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;
We found this trial at
11
sites
181 Russell Street
Lewiston, Maine 04240
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Colorado Springs, Colorado 80907
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Fort Collins, Colorado 80525
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Indianapolis, Indiana 46290
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Indianapolis, IN
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Lancaster, California 93534
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Lancaster, CA
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Lexington, Kentucky 40509
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Lexington, KY
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6400 Dutchmans Parkway
Louisville, Kentucky 40205
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Louisville, KY
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Louisville, Kentucky 40206
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Louisville, KY
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11960 Lioness Way
Parker, Colorado 80134
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Parker, CO
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Rapid City, South Dakota 57701
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Rapid City, SD
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Washington, District of Columbia 20037
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Washington,
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