Corneal Epithelial Stem Cells and Dry Eye Disease

NCT ID: NCT03302273

Last Updated: 2022-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-04-01

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Corneal Epithelial Stem Cell Transplant

Intervention Type OTHER

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

Interventions

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Corneal Epithelial Stem Cell Transplant

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sloan W. Rush, MD

OTHER

Sponsor Role lead

Responsible Party

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Sloan W. Rush, MD

Physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Rush Eye Associates

Amarillo, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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5

Identifier Type: -

Identifier Source: org_study_id

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