The Effect of Warm Compress Therapy Using the TearRestore Eyelid Warming Mask on Symptoms and Signs of Meibomian Gland Function
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire
研究概览
简要总结
This study plans to learn more about the effectiveness of the TearRestore eyelid warming mask on signs and symptoms of Meibomian Gland Dysfunction (MGD). MGD is a leading cause of dry eye symptoms. Warm compresses are a standard treatment recommended by physicians to treat those diagnosed with MGD. The study will investigate whether the TearRestore mask affects meibomian gland function and dry eye symptoms.
详细描述
The study will evaluate the effectiveness of the TearRestore eyelid warming mask on signs and symptoms of MGD. Warm compress treatments have been recommended as part of the standard of care by eye physicians, and are an important means in treating MGD. However, current treatment options suffer from varied temperature maintenance and poor compliance. The TearRestore™ mask offers patients a unique experience through providing sustained heat and the ability to see throughout the treatment, which will improve efficacy through improved compliance. If shown to be effective in altering Meibomian gland secretions at a single visit, this novel treatment could potentially offer the millions of patients suffering from MGD a more convenient and effective way to treat the condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants (age 18-89) of any race, gender or ethnicity, diagnosed with meibomian gland dysfunction
- •Symptom score greater than eight on the SPEED questionnaire
- •Less than 75nm lipid layer thickness (LLT) utilizing the Lipiview II
- •Less than 10 second tear break up time (average of 3 measurements)
排除标准
- •Participants with less than 6/15 meibomian glands yielding liquid secretions in either eyelid
- •Diagnosed with a systemic autoimmune condition including but not limited to Sjogren's or Lupus
研究组 & 干预措施
Single 10 minute session
Study assessments will be performed before single 10 minute session of wearing the Tear Restore Mask and then study assessments will be repeated after the 10 minute single session has been completed.
干预措施: Tear Restore Mask (Device)
Optional Extension
Subjects can choose to extend use of the Tear Restore Mask at home for a period of 28 to 60 days. They will use the mask for a 10 minute time period one time per day and record the use in a diary.
干预措施: Tear Restore Mask (Device)
结局指标
主要结局
Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire
时间窗: Up to 60 days
The SPEED questionnaire will be completed by the subject prior to using the Tear Restore Mask and then repeated after the 10 minute session
次要结局
- Lipid Layer Thickness(Up to 60 days)
- Tear Breakup Time(Up to 60 days)
- Number of Meibomian Glands Yielding Liquid Secretions(Up to 60 days)