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Trial record 1 of 1 for:    NCT03302273
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Corneal Epithelial Stem Cells and Dry Eye Disease

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ClinicalTrials.gov Identifier: NCT03302273
Recruitment Status : Completed
First Posted : October 5, 2017
Last Update Posted : April 21, 2022
Sponsor:
Information provided by (Responsible Party):
Sloan W. Rush, MD, Panhandle Eye Group, LLP

Tracking Information
First Submitted Date  ICMJE September 30, 2017
First Posted Date  ICMJE October 5, 2017
Last Update Posted Date April 21, 2022
Actual Study Start Date  ICMJE February 1, 2019
Actual Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2017)
Ocular Surface Disease Index (OSDI) [ Time Frame: 3 months ]
Patient Reported Outcome by Survey
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2017)
  • Visual Acuity [ Time Frame: 3 months ]
    Snellen
  • Corneal Topography [ Time Frame: 3 months ]
    Automated corneal topographic indices
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Corneal Epithelial Stem Cells and Dry Eye Disease
Official Title  ICMJE Topical Cadaveric-Derived Corneal Epithelial Stem Cell Transplant Therapy for the Treatment of Severe Dry Eye Disease
Brief Summary To study of a novel, therapeutic Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) in the treatment of severe dry eye disease that is failing conventional treatments. This pilot study will carefully observe and monitor each qualifying and willing individual for response to treatment, signs of toxicity and adverse effects from the treatment, and for ability of the treatment to improve comfort and restore vision.
Detailed Description Eligible patients presenting with severe dry eye disease that have failed treatment with conventional measures will be screened for inclusion into the study. The treatment will consist of administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived product. These eye drops will be transplanted by topical self-administration by the patient four times daily in both eyes for a three month interval.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Dry Eye Syndromes
  • Dry Eye
  • Ocular Inflammation
  • Ocular Surface Disease
  • Ocular Discomfort
  • Blepharitis
Intervention  ICMJE Other: Corneal Epithelial Stem Cell Transplant
Self-administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material.
Study Arms  ICMJE Experimental: Corneal Epithelial Stem Cell Transplant
The treatment will consist of transplantation (via self-administration) of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material four times daily in both eyes for a three month interval.
Intervention: Other: Corneal Epithelial Stem Cell Transplant
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2020)
17
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2017)
30
Actual Study Completion Date  ICMJE April 1, 2022
Actual Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of advanced dry eye disease
  • Severe dry eye symptoms despite having tried over a half dozen treatments

Exclusion Criteria:

  • Not willing to undergo clinical trial
  • Unable to comply with treatment regimen
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03302273
Other Study ID Numbers  ICMJE 5
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Sloan W. Rush, MD, Panhandle Eye Group, LLP
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sloan W. Rush, MD
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Panhandle Eye Group, LLP
Verification Date April 2022

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