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Corneal Epithelial Stem Cells and Dry Eye Disease

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ClinicalTrials.gov Identifier: NCT03302273
Recruitment Status : Recruiting
First Posted : October 5, 2017
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Sloan W. Rush, MD, Panhandle Eye Group, LLP

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : February 1, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

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.




Primary Outcome Measures :
  1. Ocular Surface Disease Index (OSDI) [ Time Frame: 3 months ]
    Patient Reported Outcome by Survey


Secondary Outcome Measures :
  1. Visual Acuity [ Time Frame: 3 months ]
    Snellen

  2. Corneal Topography [ Time Frame: 3 months ]
    Automated corneal topographic indices



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302273


Contacts
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Contact: Sloan Rush, MD 806-353-0125 sunday.fowler@paneye.com

Locations
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United States, Texas
Rush Eye Associates Recruiting
Amarillo, Texas, United States, 79109
Contact: Sloan Rush, MD    806-353-0125    sunday.fowler@paneye.com   
Contact: Sunday Fowler, COA    806-353-0125    sunday.fowler@paneye.com   
Sub-Investigator: Hiranmoy Das, PhD         
Sponsors and Collaborators
Sloan W. Rush, MD

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Responsible Party: Sloan W. Rush, MD, Physician, Panhandle Eye Group, LLP
ClinicalTrials.gov Identifier: NCT03302273     History of Changes
Other Study ID Numbers: 5
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Panhandle Eye Group, LLP:
stem cell therapy
dry eye disease

Additional relevant MeSH terms:
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Inflammation
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Blepharitis
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Eyelid Diseases