Corneal Epithelial Stem Cells and Dry Eye Disease

• ClinicalTrials.gov Identifier: NCT03302273
• Recruitment Status: Completed
• First Posted: October 5, 2017
• Last Update Posted: April 21, 2022
• Sponsor: Sloan W. Rush, MD
• Information provided by (Responsible Party): Sloan W. Rush, MD, Panhandle Eye Group, LLP

Tracking Information

• First Submitted Date: September 30, 2017
• First Posted Date: October 5, 2017
• Last Update Posted Date: April 21, 2022
• Actual Study Start Date: February 1, 2019
• Actual Primary Completion Date: April 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 3, 2017)

Ocular Surface Disease Index (OSDI) [ Time Frame: 3 months ]

Patient Reported Outcome by Survey

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 3, 2017)

• Visual Acuity [ Time Frame: 3 months ]
  Snellen
• Corneal Topography [ Time Frame: 3 months ]
  Automated corneal topographic indices

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Corneal Epithelial Stem Cells and Dry Eye Disease
• Official Title: Topical Cadaveric-Derived Corneal Epithelial Stem Cell Transplant Therapy for the Treatment of Severe Dry Eye Disease
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Dry Eye Syndromes
• Dry Eye
• Ocular Inflammation
• Ocular Surface Disease
• Ocular Discomfort
• Blepharitis

Intervention

Other: Corneal Epithelial Stem Cell Transplant

Self-administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material.

Study Arms

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.

Intervention: Other: Corneal Epithelial Stem Cell Transplant

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 2, 2020): 17
• Original Estimated Enrollment (submitted: October 3, 2017): 30
• Actual Study Completion Date: April 1, 2022
• Actual Primary Completion Date: April 1, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03302273
• Other Study ID Numbers: 5
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Sloan W. Rush, MD, Panhandle Eye Group, LLP
• Original Responsible Party: Same as current
• Current Study Sponsor: Sloan W. Rush, MD
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Panhandle Eye Group, LLP
• Verification Date: April 2022