Corneal Epithelial Stem Cells and Dry Eye Disease

Sponsor
Sloan W. Rush, MD (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03302273
Collaborator
(none)
17
Enrollment
1
Location
1
Arm
48
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • 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
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

ArmIntervention/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

SiteCityStateCountryPostal Code
1Rush Eye AssociatesAmarilloTexasUnited States79109

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:
Mar 10, 2021
Last Verified:
Mar 1, 2021
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2021