NCT03302273

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2017

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

3.2 years

First QC Date

September 30, 2017

Last Update Submit

April 20, 2022

Conditions

Dry Eye SyndromesDry EyeOcular InflammationOcular Surface DiseaseOcular DiscomfortBlepharitis

Keywords

stem cell therapydry eye disease

Outcome Measures

Primary Outcomes (1)

  • Ocular Surface Disease Index (OSDI)

    Patient Reported Outcome by Survey

    3 months

Secondary Outcomes (2)

  • Visual Acuity

    3 months

  • Corneal Topography

    3 months

Study Arms (1)

Corneal Epithelial Stem Cell Transplant

EXPERIMENTAL

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

Interventions

Corneal Epithelial Stem Cell TransplantOTHER

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

Corneal Epithelial Stem Cell Transplant

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of advanced dry eye disease
  • Severe dry eye symptoms despite having tried over a half dozen treatments

You may not qualify if:

  • Not willing to undergo clinical trial
  • Unable to comply with treatment regimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush Eye Associates

Amarillo, Texas, 79109, United States

Location

MeSH Terms

Conditions

Dry Eye SyndromesBlepharitis

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesEyelid Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

September 30, 2017

First Posted

October 5, 2017

Study Start

February 1, 2019

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

April 21, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)