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. The aim is 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.
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.
| Study Type : |
Interventional (Clinical Trial) |
| Estimated Enrollment : |
30 participants |
| Intervention Model: |
Single Group Assignment |
| Masking: |
None (Open Label) |
| Primary Purpose: |
Treatment |
| Official Title: |
Topical Cadaveric-Derived Corneal Epithelial Stem Cell Transplant Therapy for the Treatment of Severe Dry Eye Disease |
| Anticipated Study Start Date : |
November 1, 2017 |
| Estimated Primary Completion Date : |
October 1, 2019 |
| Estimated Study Completion Date : |
October 1, 2019 |
For enrollment please visit www.clinicaltrials.gov.
