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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02600429
Recruitment Status : Terminated (Business decision)
First Posted : November 9, 2015
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
ReGenTree, LLC

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
Neurotrophic Keratopathy Drug: RGN-259 Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
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 : September 17, 2015
Actual Primary Completion Date : November 20, 2019
Actual Study Completion Date : March 9, 2020

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 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




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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 ]
  3. Tear Film Break-up Time at 29, 36, 43 days after first dosing [ Time Frame: 29, 36, 43 days after first dosing ]
  4. 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 ]
  5. 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:
  1. 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 ]
  2. 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 ]
  3. Corneal Sensitivity using the aesthesiometer (Cochet-Bonnet) at 1, 8, 15, 29 days after first dosing [ Time Frame: 29, 43 days after first dosing ]
  4. 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 ]
  5. Change in biomicroscopy using Dilated Fundoscopy at 29, 43 days after first dosing [ Time Frame: 29, 43 days after first dosing ]
  6. Intraocular Pressure at 29, 43 days after first dosing [ Time Frame: 29, 43 days after first dosing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600429


Locations
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United States, California
Hull Eye Center
Lancaster, California, United States, 93534
United States, Colorado
Vision Institute
Colorado Springs, Colorado, United States, 80907
Eye Center of Northern Colorado
Fort Collins, Colorado, United States, 80525
Insight Vision Group
Parker, Colorado, United States, 80134
United States, District of Columbia
Medical Faculty Associates, Inc.
Washington, District of Columbia, United States, 20037
United States, Indiana
Midwest Cornea Associates, LLC
Indianapolis, Indiana, United States, 46290
United States, Kentucky
Koffler Vision Group
Lexington, Kentucky, United States, 40509
Richard Eiferman, MD, PSC
Louisville, Kentucky, United States, 40205
The Eye Care Institute
Louisville, Kentucky, United States, 40206
United States, Maine
Central Maine Eye Care
Lewiston, Maine, United States, 04240
United States, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701
Sponsors and Collaborators
ReGenTree, LLC
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Responsible Party: ReGenTree, LLC
ClinicalTrials.gov Identifier: NCT02600429    
Other Study ID Numbers: RGN-NK-301
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by ReGenTree, LLC:
Neurotrophic Keratopathy
NK