Dry Eye SyndromesNCT03302273
Corneal Epithelial Stem Cells and Dry Eye Disease
A study testing Corneal Epithelial Stem Cell Transplant in people with Dry Eye Syndromes and Dry Eye, run by Sloan W. Rush, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Dry Eye Syndromes, Dry Eye, Ocular Inflammation
- What is being tested?
- Corneal Epithelial Stem Cell Transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of advanced dry eye disease
- Severe dry eye symptoms despite having tried over a half dozen treatments
Who cannot join
- Not willing to undergo clinical trial
- Unable to comply with treatment regimen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Cadaveric-Derived Corneal Epithelial Stem Cell Transplant Therapy for the Treatment of Severe 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.
Read the 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.
- Conditions
- Dry Eye Syndromes, Dry Eye, Ocular Inflammation, Ocular Surface Disease, Ocular Discomfort, Blepharitis
- Being tested
- Corneal Epithelial Stem Cell Transplant
- Keywords
- stem cell therapy, dry eye disease
- Medical subject headings
- Dry Eye Syndromes, Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal Epithelial Stem Cell TransplantOther
Self-administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Corneal Epithelial Stem Cell Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index (OSDI)
Patient Reported Outcome by Survey
Measured: 3 months
Secondary outcomes (2)
Visual Acuity
Snellen
Measured: 3 months
Corneal Topography
Automated corneal topographic indices
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start1 Feb 2019
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sloan W. Rush, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sloan W. Rush, MD, Panhandle Eye Group, LLP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302273
- Sponsor's protocol ID
- 5
- Status last verified
- Apr 2022
- First submitted
- 30 Sep 2017
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Cadaveric-Derived Corneal Epithelial Stem Cell Transplant Therapy for the Treatment of Severe Dry Eye Disease
- ClinicalTrials.gov ID
- NCT03302273
- Acronym / sponsor ID
- 5
- Conditions
- Dry Eye Syndromes, Dry Eye, Ocular Inflammation, Ocular Surface Disease, Ocular Discomfort, Blepharitis
- Keywords
- stem cell therapy, dry eye disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Sloan W. Rush, MDUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 5 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corneal Epithelial Stem Cell Transplant | Experimental | Other: Corneal Epithelial Stem Cell TransplantThe 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of advanced dry eye disease
- Severe dry eye symptoms despite having tried over a half dozen treatments
Key exclusion criteria (2 listed)
- Not willing to undergo clinical trial
- Unable to comply with treatment regimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corneal Epithelial Stem Cell TransplantSelf-administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material. | Other | Corneal Epithelial Stem Cell Transplant |
Primary outcome
Ocular Surface Disease Index (OSDI)
Time frame: 3 months
Patient Reported Outcome by Survey
2 secondary outcomes
Visual Acuity
Time frame: 3 months
Corneal Topography
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corneal Epithelial Stem Cell Transplant in people with Dry Eye Syndromes and Dry Eye, run by Sloan W. Rush, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Surface Disease Index (OSDI) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.