Corneal Epithelial Stem Cells and Dry Eye Disease

Sloan W. Rush, MD

Status: Completed

Conditions: Blepharitis; Dry Eye; Dry Eye Syndromes; Ocular Surface Disease; Ocular Inflammation; Ocular Discomfort

Treatments: Other: Corneal Epithelial Stem Cell Transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT03302273

5

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Corneal Epithelial Stem Cell Transplant

Experimental group

Description:

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.

Treatment:

Other: Corneal Epithelial Stem Cell Transplant