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Evaluation of SUMMIT BRUSH in Treatment of Blepharitis
NCT04603222 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Notre Dame, which has 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04603222 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Colorado, Indiana, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04603222?
The interventions under investigation include: SUMMIT BRUSH (DEVICE), Ocusoft Lid Scrub Original Foaming Eyelid Cleanser (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04603222?
This trial is sponsored by University of Notre Dame, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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