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NCT Number: NCT03302273

Corneal Epithelial Stem Cells and Dry Eye Disease

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.

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Key information

Conditions

Dry Eye Syndromes Blepharitis Dry Eye Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases Ocular Discomfort Ocular Inflammation Ocular Surface Disease

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush Eye Associates

Amarillo, Texas, 79109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corneal Epithelial Stem Cell Transplant

Other

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

Primary outcomes

  1. Ocular Surface Disease Index (OSDI)

    Time frame: 3 months

    Patient Reported Outcome by Survey

Secondary outcomes

  1. Visual Acuity

    Time frame: 3 months

    Snellen

  2. Corneal Topography

    Time frame: 3 months

    Automated corneal topographic indices

Sponsors and collaborators

Lead sponsor

Sloan W. Rush, MD

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 5, 2017
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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