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

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Disease Information

Descriptive Information
Brief Title † Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1
Official Title † 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
Brief 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.
Study Phase Phase 3
Study Type † Interventional
Study Design †
Primary Outcome Measure † Percentage of subjects achieving complete healing at day 29.
Secondary Outcome Measure † Percentage of subjects achieving complete healing at 8, 15, 22, 36, 43 days
Condition † Neurotrophic Keratopathy
Intervention † DrugRGN-259
Study Arms / Comparison Groups RGN-259 It is a preservative-free, sterile eye drop solution containing Tβ4 Placebo It is composed of the same excipients as RGN-259 but does not contain Tβ4.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 46
Start Date † September 2015
Completion Date May 2017
Primary Completion Date May 2017
Eligibility Criteria † 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;
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Won S Yang, 609-649-5505, wonsyang@regentreellc.com
Location Countries † United States
Administrative Information
NCT ID † NCT02600429
Organization ID RGN-NK-301
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † ReGenTree, LLC
Collaborators ††
Investigators † Principal Investigator: Richard Eiferman, MD, Richard Eiferman, MD, PSC
Information Provided By
Verification Date March 2017
First Received Date † October 26, 2015
Last Updated Date March 7, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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