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
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- ReGenTree, LLC
- Enrollment
- 18
- Locations
- 11
- Primary Endpoint
- Percentage of Subjects Achieving Complete Healing at Day 29.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
Placebo
It is composed of the same excipients as RGN-259 but does not contain Tβ4.
Intervention: Placebo (Drug)
RGN-259
It is a preservative-free, sterile eye drop solution containing Tβ4
Intervention: RGN-259 (Drug)
Outcomes
Primary Outcomes
Percentage of Subjects Achieving Complete Healing at Day 29.
Time Frame: 29 days after first dosing
Percentage of subjects achieving complete healing of the persistent epithelial defect as determined by corneal fluorescein staining at day 29 after first dosing.
Secondary Outcomes
- Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification.(8, 15, 22, 29, 36, 43 days after first dosing)
- Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days(8, 15, 22, 36, 43 days after first dosing)
- Tear Film Break-up Time at 29, 36, 43 Days(29, 36, 43 days after first dosing)
- Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing(8, 15, 22, 29, 36, 43 days after first dosing)
- Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days(8, 15, 22, 29, 36, 43 days after first dosing)