Clinical trial NCT02600429: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Neurotrophic Keratopathy
Keywords: Neurotrophic Keratopathy
NK
Lead sponsor: ReGenTree, LLC
Sponsor class: INDUSTRY
First posted: 2015-11-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Percentage of Subjects Achieving Complete Healing at Day 29.
timeFrame: 29 days after first dosing
Secondary outcomes:
measure: Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days
timeFrame: 8, 15, 22, 36, 43 days after first dosing
measure: Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification.
timeFrame: 8, 15, 22, 29, 36, 43 days after first dosing
measure: Tear Film Break-up Time at 29, 36, 43 Days
timeFrame: 29, 36, 43 days after first dosing
measure: Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing
timeFrame: 8, 15, 22, 29, 36, 43 days after first dosing
measure: Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days
timeFrame: 8, 15, 22, 29, 36, 43 days after first dosing
Other outcomes:
measure: The Number of Participants With an Abnormal Findings by Slit-lamp Biomicroscopy at 8, 15, 22, 29, 36, 43 Days
timeFrame: 8, 15, 22, 29, 36, 43 days after first dosing
measure: Corneal Sensitivity Using the Aesthesiometer (Cochet-Bonnet)
timeFrame: 29, 43 days after first dosing
measure: The Number of Participants With an Abnormal Findings by Dilated Fundoscopy at 29, 43 Days
timeFrame: 29, 43 days after first dosing
measure: Intraocular Pressure
timeFrame: 29, 43 days after first dosing
Locations:
city: Lancaster
country: United States
facility: Hull Eye Center
state: California
city: Colorado Springs
country: United States
facility: Vision Institute
state: Colorado
city: Fort Collins
country: United States
facility: Eye Center of Northern Colorado
state: Colorado
city: Parker
country: United States
facility: Insight Vision Group
state: Colorado
city: Washington
country: United States
facility: Medical Faculty Associates, Inc.
state: District of Columbia
city: Indianapolis
country: United States
facility: Midwest Cornea Associates, LLC
state: Indiana
city: Lexington
country: United States
facility: Koffler Vision Group
state: Kentucky
city: Louisville
country: United States
facility: Richard Eiferman, MD, PSC
state: Kentucky
city: Louisville
country: United States
facility: The Eye Care Institute
state: Kentucky
city: Lewiston
country: United States
facility: Central Maine Eye Care
state: Maine
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
Study officials:
References: