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临床试验/NCT04603222
NCT04603222招募中不适用

Evaluation of SUMMIT BRUSH in Treatment of Blepharitis

University of Notre Dame6 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
6
主要终点
Change in blepharitis severity on eye lid margins

研究概览

简要总结

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.

详细描述

Dry Eye Disease is a multifactorial disease that affects approximately 15-30 million people in the United States alone. it creates an enormous societal and economic burden, decreases productivity in our workplace, and significantly affects the quality of lives of the people affected by this disease. Appoximately 86% of Dry Eye Disease is caused by Blepharitis, a chronic inflammation of the eyelid margins. If left untreated, Blepharitis results in the obstruction and eventual loss of the glands responsible for a critical component of tear film production.

The standard of care in the treatment of Blepharitis is the use of self administered at home commercially available products such as eyelid foams, gels, and pre moistened pads. These products contain non abrasive cleansers designed to remove the buildup of biofilm and excess microorganisms on the lid margin. Although these products are helpful, they do have some limitations. Many patients still require more expensive in office procedures such as lid debridement with electro-mechanical exfoliation devices or other even 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 commonly prescribed commercially available 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 (scurfs, collarettes, and demodex) than the cleanser alone.

Hypothesis: The Summit Ocular Brush used in conjunction with Ocusoft Original lid cleanser is more effective than the cleanser alone at removing the debris (scurfs, collarettes, and demodex) from the eyelids in the treatment and management of Blepharitis.

The investigators want to determine if the addition of the ocular brush with the eyelid cleanser has synergistic effects on reducing the signs and symptoms of Blepharitis and Dry Eye Disease. They also hope to learn that with this additional step, further and more expensive procedures could be avoided thereby decreasing the overall economic burden on the patient and society as a whole.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

All SPEED scores and digital images would then be de-identified to avoid any bias by the principal investigator and his research staff.

These scores and images would be uploaded and sent electronically via encrypted password protected file to Giles Duffield, PhD. for interpretation and statistical analysis.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical signs and symptoms of blepharitis (Staphylococcal and Demodex).
  • Must exhibit visible collarettes, clear sleeves, and scurfs on the eyelid margins upon Slit Lamp Biomicroscopy.

排除标准

  • Hordeolum
  • Chalazion
  • Periorbital cellulitis
  • Allergic eyelid dermatitis.
  • Acute bacterial conjunctivitis
  • Open periorbital wounds.

结局指标

主要结局

Change in blepharitis severity on eye lid margins

时间窗: Initial visit, 2 week follow up, and 4 week follow up

Digital photography will be used to asses the eye lid margins pre-treatment, during treatment, and post-treatment. The number of collarettes on the eyelashes will be counted at each visit.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giles Duffield

Principal Investigator

University of Notre Dame

研究点 (6)

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