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

Sponsor
ReGenTree, LLC (Industry)
Overall Status
Terminated
CT.gov ID
NCT02600429
Collaborator
(none)
18
Enrollment
11
Locations
2
Arms
53.7
Actual Duration (Months)
1.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 17, 2015
Actual Primary Completion Date :
Nov 20, 2019
Actual Study Completion Date :
Mar 9, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: RGN-259

It is a preservative-free, sterile eye drop solution containing Tβ4

Drug: RGN-259
A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into affected eye(s), five times a day for 4 weeks.
Other Names:
  • Tβ4

    		•
    Placebo Comparator: Placebo

    It is composed of the same excipients as RGN-259 but does not contain Tβ4.

    Drug: Placebo
    It is composed of the same excipients as RGN-259 but does not contain Tβ4
    Other Names:
  • Vehicle Control

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of subjects achieving complete healing at day 29. [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 Outcome Measures

    1. Percentage of subjects achieving complete healing at 8, 15, 22, 36, 43 days [8, 15, 22, 36, 43 days after first dosing]

      Percentage of subjects achieving complete healing of the persistent epithelial defect determined by corneal fluorescein staining at 8, 15, 22, 36, 43 days after first dosing.

    2. Epithelial Defect Measurement and Classification as stage 1, 2 or 3 using Mackie Classification. [8, 15, 22, 29, 36, 43 days after first dosing]

    3. Tear Film Break-up Time at 29, 36, 43 days after first dosing [29, 36, 43 days after first dosing]

    4. 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]

    5. Visual acuity at 8, 15, 22, 29, 36, 43 days after first dosing [8, 15, 22, 29, 36, 43 days after first dosing]

    Other Outcome Measures

    1. Visual acuity (ETDRS, ETDRS, Early Treatment Diabetic Retinopathy Study scal ) at 8, 15, 22, 29, 36, 43 days after first dosing [8, 15, 22, 29, 36, 43 days after first dosing]

    2. Change in biomicroscopy using slit-lamp at 8, 15, 22, 29, 36, 43 days after first dosing [8, 15, 22, 29, 36, 43 days after first dosing]

    3. Corneal Sensitivity using the aesthesiometer (Cochet-Bonnet) at 1, 8, 15, 29 days after first dosing [29, 43 days after first dosing]

    4. Adverse event query at Visits at 8, 15, 22, 29, 36, 43 days after first dosing [8, 15, 22, 29, 36, 43 days after first dosing]

    5. Change in biomicroscopy using Dilated Fundoscopy at 29, 43 days after first dosing [29, 43 days after first dosing]

    6. Intraocular Pressure at 29, 43 days after first dosing [29, 43 days after first dosing]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hull Eye Center Lancaster California United States 93534
    2 Vision Institute Colorado Springs Colorado United States 80907
    3 Eye Center of Northern Colorado Fort Collins Colorado United States 80525
    4 Insight Vision Group Parker Colorado United States 80134
    5 Medical Faculty Associates, Inc. Washington District of Columbia United States 20037
    6 Midwest Cornea Associates, LLC Indianapolis Indiana United States 46290
    7 Koffler Vision Group Lexington Kentucky United States 40509
    8 Richard Eiferman, MD, PSC Louisville Kentucky United States 40205
    9 The Eye Care Institute Louisville Kentucky United States 40206
    10 Central Maine Eye Care Lewiston Maine United States 04240
    11 Black Hills Regional Eye Institute Rapid City South Dakota United States 57701

    Sponsors and Collaborators

    • ReGenTree, LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ReGenTree, LLC
    ClinicalTrials.gov Identifier:
    NCT02600429
    Other Study ID Numbers:
    • RGN-NK-301
    First Posted:
    Nov 9, 2015
    Last Update Posted:
    Jul 2, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by ReGenTree, LLC
    Neurotrophic Keratopathy
    NK

    Study Results

    No Results Posted as of Jul 2, 2020