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

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ClinicalTrials.gov Identifier: NCT02600429
Recruitment Status : Recruiting
First Posted : November 9, 2015
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
ReGenTree, LLC

Tracking Information
First Submitted Date  ICMJE October 26, 2015
First Posted Date  ICMJE November 9, 2015
Last Update Posted Date March 5, 2019
Actual Study Start Date  ICMJE September 2015
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02600429 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 9, 2016)
  • 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 ]
Original Other Pre-specified Outcome Measures
 (submitted: November 6, 2015)
  • 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 useing 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 useing 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 ]
 
Descriptive Information
Brief Title  ICMJE Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neurotrophic Keratopathy
Intervention  ICMJE
  • 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
  • Drug: Placebo
    It is composed of the same excipients as RGN-259 but does not contain Tβ4
    Other Name: Vehicle Control
Study Arms  ICMJE
  • Experimental: RGN-259
    It is a preservative-free, sterile eye drop solution containing Tβ4
    Intervention: Drug: RGN-259
  • Placebo Comparator: Placebo
    It is composed of the same excipients as RGN-259 but does not contain Tβ4.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2015)
46
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shinwook Kang 609-649-5505 swkang@regentreellc.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02600429
Other Study ID Numbers  ICMJE RGN-NK-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ReGenTree, LLC
Study Sponsor  ICMJE ReGenTree, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard Eiferman, MD Richard Eiferman, MD, PSC
PRS Account ReGenTree, LLC
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP