Back to resultsCorneal Epithelial Stem Cells and Dry Eye Disease
Primary Purpose
Dry Eye Syndromes, Dry Eye, Ocular Inflammation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Corneal Epithelial Stem Cell Transplant
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes focused on measuring stem cell therapy, dry eye disease
Eligibility Criteria
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
Sites / Locations
- Rush Eye Associates
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Corneal Epithelial Stem Cell Transplant
Arm Description
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.
Outcomes
Primary Outcome Measures
Ocular Surface Disease Index (OSDI)
Patient Reported Outcome by Survey
Secondary Outcome Measures
Visual Acuity
Snellen
Corneal Topography
Automated corneal topographic indices
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03302273
Brief Title
Corneal Epithelial Stem Cells and Dry Eye Disease
Official Title
Topical Cadaveric-Derived Corneal Epithelial Stem Cell Transplant Therapy for the Treatment of Severe Dry Eye Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sloan W. Rush, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Dry Eye, Ocular Inflammation, Ocular Surface Disease, Ocular Discomfort, Blepharitis
Keywords
stem cell therapy, dry eye disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Corneal Epithelial Stem Cell Transplant
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Corneal Epithelial Stem Cell Transplant
Intervention Description
Self-administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material.
Primary Outcome Measure Information:
Title
Ocular Surface Disease Index (OSDI)
Description
Patient Reported Outcome by Survey
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Visual Acuity
Description
Snellen
Time Frame
3 months
Title
Corneal Topography
Description
Automated corneal topographic indices
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rush Eye Associates
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Corneal Epithelial Stem Cells and Dry Eye Disease
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