Corneal Epithelial Stem Cells and Dry Eye Disease

• Sponsor: Sloan W. Rush, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT03302273
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arm: 1
• Actual Duration (Months): 37.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes; Dry Eye; Ocular Inflammation; Ocular Surface Disease; Ocular Discomfort; Blepharitis	Other: Corneal Epithelial Stem Cell Transplant	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Topical Cadaveric-Derived Corneal Epithelial Stem Cell Transplant Therapy for the Treatment of Severe Dry Eye Disease
• Actual Study Start Date: Feb 1, 2019
• Actual Primary Completion Date: Apr 1, 2022
• Actual Study Completion Date: Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Corneal Epithelial Stem Cell Transplant; Self-administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material.

Outcome Measures

Primary Outcome Measures

1. Ocular Surface Disease Index (OSDI) [3 months]

   Patient Reported Outcome by Survey

Secondary Outcome Measures

1. Visual Acuity [3 months]

   Snellen

2. Corneal Topography [3 months]

   Automated corneal topographic indices

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush Eye Associates	Amarillo	Texas	United States	79109

Sponsors and Collaborators

• Sloan W. Rush, MD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sloan W. Rush, MD, Physician, Panhandle Eye Group, LLP
• ClinicalTrials.gov Identifier: NCT03302273
• Other Study ID Numbers: 5
• First Posted: Oct 5, 2017
• Last Update Posted: Apr 21, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sloan W. Rush, MD, Physician, Panhandle Eye Group, LLP: stem cell therapy; dry eye disease
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Blepharitis; Inflammation

Study Results

No Results Posted as of Apr 21, 2022