Corneal Epithelial Stem Cells and Dry Eye Disease

Not Applicable

Completed

• Conditions: Ocular Surface Disease; Dry Eye Syndromes; Dry Eye; Ocular Inflammation; Ocular Discomfort; Blepharitis
• Interventions: Other: Corneal Epithelial Stem Cell Transplant

• Registration Number: NCT03302273
• Lead Sponsor: Sloan W. Rush, MD

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-09-30
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-05
• Study Start: 2019-02-01
• Status Verified: 2022-04
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Corneal Epithelial Stem Cell Transplant	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.

Primary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index (OSDI)	3 months	Patient Reported Outcome by Survey

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	3 months	Snellen
Corneal Topography	3 months	Automated corneal topographic indices

Trial Locations

Locations (1)

Rush Eye Associates; 🇺🇸 Amarillo, Texas, United States