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NCT04603222 · ClinicalTrials.gov registry record · NA
Evaluation of SUMMIT BRUSH in Treatment of Blepharitis
A NA study of Blepharitis, sponsored by University of Notre Dame.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT04603222 is a NA study of Blepharitis that is actively recruiting participants, run by University of Notre Dame. The registered enrollment target is 60 participants, above the 50-participant average among 6 other Blepharitis trials with a reported enrollment target (20% higher). The trial reports 3 study locations across 3 states.
The verdict
NCT04603222, a NA study of Blepharitis, is actively recruiting participants, sponsored by University of Notre Dame.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study Summary
Dry Eye Disease (DED) is a multifactorial disease that affects \~15-30 million people in the USA alone. It creates an enormous societal and economic burden, decreases productivity in the workplace, and affects the quality of lives of the people affected by this disease. DED is primarily caused by blepharitis, a chronic inflammation of the eyelid margins. If left untreated, blepharitis results in the obstruction and loss of the glands responsible for tear film production. The standard of care is the use of self-administered at home commercially available products, e.g., eyelid foams, gels, and pads. Although these products are helpful, they have limitations. Patients often require expensive in office procedures, e.g., lid debridement with exfoliation devices or more expensive procedures. The scope of this project is to evaluate the effectiveness of a new self-administered disposable ocular brush used in conjunction with the most common eyelid cleanser. The investigators are looking to see if combining the microexfoliation provided by the brush with the eyelid cleanser is more effective at removing the eyelid debris than the cleanser alone.
Conditions Studied
Interventions
- DEVICE SUMMIT BRUSH
- OTHER Ocusoft Lid Scrub Original Foaming Eyelid Cleanser
Study Locations (3)
Colorado
- University of Colorado - Boulder
Indiana
- Michiana Eye Center - Mishawaka
Kentucky
- Kentucky Eye Institute - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-07-21 |
| Est. Completion | 2022-07-18 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04603222
The ClinicalTrials.gov registry entry for NCT04603222 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 50-participant average among 6 other Blepharitis trials with a reported enrollment target (20% higher). The listed sponsor is University of Notre Dame, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Blepharitis appearing as the primary indexed condition, and to 2 interventions - of which SUMMIT BRUSH is the first listed.
NCT04603222 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Colorado, Indiana, Kentucky.
Frequently Asked Questions
What is clinical trial NCT04603222 about?
NCT04603222 is a clinical study titled "Evaluation of SUMMIT BRUSH in Treatment of Blepharitis". Dry Eye Disease (DED) is a multifactorial disease that affects \~15-30 million people in the USA alone. It creates an enormous societal and economic burden, decreases productivity in the workplace, and affects the quality of lives of the people affected by this disease. DED is primarily caused by bl...
What is the current status of trial NCT04603222?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2020-07-21. Estimated completion is 2022-07-18.
What conditions does trial NCT04603222 study?
This clinical trial studies the following conditions: Blepharitis.
What interventions are being tested in trial NCT04603222?
The interventions under investigation include: SUMMIT BRUSH (DEVICE), Ocusoft Lid Scrub Original Foaming Eyelid Cleanser (OTHER).
Who is sponsoring clinical trial NCT04603222?
This trial is sponsored by University of Notre Dame, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04603222 being conducted?
This trial has 3 study locations across Colorado, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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