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NCT03302273 Clinical Trial

Corneal Epithelial Stem Cells and Dry Eye Disease

Dry Eye Clinical Trial

Official title:
Topical Cadaveric-Derived Corneal Epithelial Stem Cell Transplant Therapy for the Treatment of Severe Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03302273
Other study ID # 5
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date April 1, 2022

Study information
Verified date April 2022
Source Panhandle Eye Group, LLP
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date April 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Corneal Epithelial Stem Cell Transplant
Self-administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material.

Locations
Country Name City State
United States Rush Eye Associates Amarillo Texas

Sponsors (1)
Lead Sponsor Collaborator
Sloan W. Rush, MD

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ocular Surface Disease Index (OSDI) Patient Reported Outcome by Survey 3 months
Secondary Visual Acuity Snellen 3 months
Secondary Corneal Topography Automated corneal topographic indices 3 months
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