An interventional study of Corneal Epithelial Stem Cell Transplant in Dry Eye Syndromes, Dry Eye and Ocular Inflammation, sponsored by Sloan W. Rush, MD. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-04-21.
Sponsored by Sloan W. Rush, MD · Not applicable, Interventional, and Treatment
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.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 17 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Sloan W. Rush, MD is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Ocular Surface Disease Index (OSDI)
Patient Reported Outcome by Survey
Time frame: 3 months
Visual Acuity
Snellen
Time frame: 3 months
Corneal Topography
Automated corneal topographic indices
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2019 to primary completion in Apr 2022, 38 months.
Of 199 non-industry interventional studies with no phase under Dry Eye Syndromes, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's 38 months is above that.
Counting every sponsor, half of 312 studies reached it within 10 months; a quarter within 4 and three quarters within 18.
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Sloan W. Rush, MD