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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by ReGenTree, LLC
Sponsor:
Information provided by (Responsible Party):
ReGenTree, LLC
ClinicalTrials.gov Identifier:
NCT02600429
First received: October 26, 2015
Last updated: March 7, 2017
Last verified: March 2017
  Purpose
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 Intervention Phase
Neurotrophic Keratopathy
Drug: RGN-259
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by ReGenTree, LLC:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Percentage of subjects achieving complete healing at 8, 15, 22, 36, 43 days [ Time Frame: 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.

  • Epithelial Defect Measurement and Classification as stage 1, 2 or 3 using Mackie Classification. [ Time Frame: 8, 15, 22, 29, 36, 43 days after first dosing ]
  • Tear Film Break-up Time at 29, 36, 43 days after first dosing [ Time Frame: 29, 36, 43 days after first dosing ]
  • Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 days after first dosing [ Time Frame: 8, 15, 22, 29, 36, 43 days after first dosing ]
  • Visual acuity at 8, 15, 22, 29, 36, 43 days after first dosing [ Time Frame: 8, 15, 22, 29, 36, 43 days after first dosing ]

Other Outcome Measures:
  • Visual acuity (ETDRS, ETDRS, Early Treatment Diabetic Retinopathy Study scal ) at 8, 15, 22, 29, 36, 43 days after first dosing [ Time Frame: 8, 15, 22, 29, 36, 43 days after first dosing ]
  • Change in biomicroscopy using slit-lamp at 8, 15, 22, 29, 36, 43 days after first dosing [ Time Frame: 8, 15, 22, 29, 36, 43 days after first dosing ]
  • Corneal Sensitivity using the aesthesiometer (Cochet-Bonnet) at 1, 8, 15, 29 days after first dosing [ Time Frame: 29, 43 days after first dosing ]
  • Adverse event query at Visits at 8, 15, 22, 29, 36, 43 days after first dosing [ Time Frame: 8, 15, 22, 29, 36, 43 days after first dosing ]
  • Change in biomicroscopy using Dilated Fundoscopy at 29, 43 days after first dosing [ Time Frame: 29, 43 days after first dosing ]
  • Intraocular Pressure at 29, 43 days after first dosing [ Time Frame: 29, 43 days after first dosing ]

Estimated Enrollment: 46
Study Start Date: September 2015
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Vehicle Control

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02600429

Contacts
Contact: Won S Yang 609-649-5505 wonsyang@regentreellc.com

Locations
United States, California
Hull Eye Center Recruiting
Lancaster, California, United States, 93534
Contact: Reginald Sampson, MD         
United States, Colorado
Eye Center of Northern Colorado Recruiting
Fort Collins, Colorado, United States, 80525
Contact: Matthew Robinson, MD         
Insight Vision Group Recruiting
Parker, Colorado, United States, 80134
Contact: C.Starck Johnson, MD         
United States, District of Columbia
Medical Faculty Associates, Inc. Recruiting
Washington, District of Columbia, United States, 20037
Contact: Craig Geist, MD         
United States, Indiana
Midwest Cornea Associates, LLC Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Clark Springs, MD         
United States, Kentucky
Koffler Vision Group Recruiting
Lexington, Kentucky, United States, 40509
Contact: Bruce Koffler, MD         
Richard Eiferman, MD, PSC Recruiting
Louisville, Kentucky, United States, 40205
Contact: Richard Eiferman, MD         
The Eye Care Institute Recruiting
Louisville, Kentucky, United States, 40206
Contact: Guruprasad R. Pattar, M.D., Ph.D.         
United States, Maine
Central Maine Eye Care Recruiting
Lewiston, Maine, United States, 04240
Contact: John Lonsdale, MD         
United States, Michigan
Michigan Cornea Consultants, PC Recruiting
Southfield, Michigan, United States, 48034
Contact: Chirag Gupta, MD         
United States, South Dakota
Black Hills Regional Eye Institute Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Stephen Khachikian, MD         
Sponsors and Collaborators
ReGenTree, LLC
Investigators
Principal Investigator: Richard Eiferman, MD Richard Eiferman, MD, PSC
  More Information

Responsible Party: ReGenTree, LLC
ClinicalTrials.gov Identifier: NCT02600429     History of Changes
Other Study ID Numbers: RGN-NK-301
Study First Received: October 26, 2015
Last Updated: March 7, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by ReGenTree, LLC:
Neurotrophic Keratopathy
NK

Additional relevant MeSH terms:
Pharmaceutical Solutions
Ophthalmic Solutions

ClinicalTrials.gov processed this record on April 21, 2017