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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corneal Epithelial Stem Cell Transplant | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corneal Epithelial Stem Cell Transplant | Other | Self-administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Disease Index (OSDI) | Patient Reported Outcome by Survey | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Snellen | 3 months |
| Corneal Topography | Automated corneal topographic indices | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush Eye Associates | Amarillo | Texas | 79109 | United States |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D001762 | Blepharitis |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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