Dry Eye Clinical Trial
Official title:
Topical Cadaveric-Derived Corneal Epithelial Stem Cell Transplant Therapy for the Treatment of Severe Dry Eye Disease
NCT number | NCT03302273 |
Other study ID # | 5 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 1, 2019 |
Est. completion date | April 1, 2022 |
Verified date | April 2022 |
Source | Panhandle Eye Group, LLP |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | April 1, 2022 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Rush Eye Associates | Amarillo | Texas |
Lead Sponsor | Collaborator |
---|---|
Sloan W. Rush, MD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ocular Surface Disease Index (OSDI) | Patient Reported Outcome by Survey | 3 months | |
Secondary | Visual Acuity | Snellen | 3 months | |
Secondary | Corneal Topography | Automated corneal topographic indices | 3 months |
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