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History of Changes for Study: NCT03302273
Corneal Epithelial Stem Cells and Dry Eye Disease
Latest version (submitted April 20, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 3, 2017 None (earliest Version on record)
2 April 3, 2018 Study Status
3 March 18, 2019 Study Status
4 March 2, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
5 March 8, 2021 Study Status
6 April 20, 2022 Recruitment Status and Study Status
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Study NCT03302273
Submitted Date:  October 3, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: 5
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
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2017
Overall Status: Recruiting
Study Start: November 1, 2017
Primary Completion: October 1, 2019 [Anticipated]
Study Completion: October 1, 2019 [Anticipated]
First Submitted: September 30, 2017
First Submitted that
Met QC Criteria:
October 3, 2017
First Posted: October 5, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
October 3, 2017
Last Update Posted: October 5, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Sloan W. Rush, MD
Responsible Party: Sponsor-Investigator
Investigator: Sloan W. Rush, MD
Official Title: Physician
Affiliation: Panhandle Eye Group, LLP
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
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.
Open or close this module Conditions
Conditions: Dry Eye Syndromes
Dry Eye
Ocular Inflammation
Ocular Surface Disease
Ocular Discomfort
Blepharitis
Keywords: stem cell therapy
dry eye disease
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Corneal Epithelial Stem Cell Transplant
Self-administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material.
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 100 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Sloan Rush, MD
Telephone: 806-353-0125
Email: sunday.fowler@paneye.com
Locations: United States, Texas
Rush Eye Associates
[Recruiting]
Amarillo, Texas, United States, 79109
Contact:Contact: Sloan Rush, MD 806-353-0125 sunday.fowler@paneye.com
Contact:Contact: Sunday Fowler, COA 806-353-0125 sunday.fowler@paneye.com
Contact:Sub-Investigator: Hiranmoy Das, PhD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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