Corneal Epithelial Stem Cells and Dry Eye Disease
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.
|Condition or Disease||Intervention/Treatment||Phase|
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.
Arms and Interventions
|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.
Other: Corneal Epithelial Stem Cell Transplant
Self-administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material.
Primary Outcome Measures
- Ocular Surface Disease Index (OSDI) [3 months]
Patient Reported Outcome by Survey
Secondary Outcome Measures
- Visual Acuity [3 months]
- Corneal Topography [3 months]
Automated corneal topographic indices
Clinical diagnosis of advanced dry eye disease
Severe dry eye symptoms despite having tried over a half dozen treatments
Not willing to undergo clinical trial
Unable to comply with treatment regimen
Contacts and Locations
|1||Rush Eye Associates||Amarillo||Texas||United States||79109|
Sponsors and Collaborators
- Sloan W. Rush, MD
Study Documents (Full-Text)None provided.