A Prospective, Single-center, Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare System in Adults With Dry Eye Disease TearCare Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Mean Change in Tear Breakup Time From Baseline to Month 1
研究概览
简要总结
This is a small, pilot study intended to determine the feasibility of this product.
详细描述
The objective of this study was to evaluate the safety and effectiveness of the TearCare® System in adult patients with clinically significant dry eye disease (DED). This was a prospective, single-center, randomized, parallel-group, clinical trial. Subjects with DED were randomized to either a single TearCare treatment conducted at the clinic or 4 weeks of daily warm compress (WC) therapy. The TearCare procedure consisted of 12 minutes of thermal eyelid treatment immediately followed by manual expression of the meibomian glands. WC therapy consisted of once daily application of the compresses to the eyelids for 5 minutes. Subjects were followed until 6 months post-treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At Least 18 Years of age
- •Reports dry eye symptoms within 3 months of the screening exam with a SPEED score >=6
- •Schirmer 1 value of <10 mm in at least one eye or a Tear Breakup time <10 seconds in at least one eye
- •Willing to comply with the study, procedures, and follow-up
- •Willing and able to provide consent
排除标准
- •Any active ocular or peri-ocular infection or inflammation
- •Recurrent eye inflammation within the past 3 months
- •Ocular surgery, oculoplastic surgery, ocular injury, Ocular Herpes Simplex, or Herpes Zoster
- •Ocular surface abnormalities that may affect tear film distribution or treatment
- •Abnormal eyelid function in either eye
- •Diminished or abnormal facial, periocular, ocular or corneal sensation
- •Ocular surface abnormalities such as corneal epithelial defects, ulcers, corneal dystrophies
- •Systemic diseases resulting in dry eye (e.g. Sjogren's syndrome)
- •Allergies to silicone tissue adhesives
- •An absence or fibrosis of the Meibomian glands (e.g. ectodermal dysplasia).
- •Unwillingness to abstain for the duration of the study from systemic medication known to cause ocular dryness (e.g. Accutane, antihistamines, etc.)
- •Anyone who requires chronic use (i.e. for any portion of the study) of topical ophthalmic antibiotics, steroids, non-steroidal anti-inflammatory medications or who has been on any of these medications within the past 30 days.
- •Unwillingness to washout and remain off certain dry eye medications for the duration of the study.
- •Participation in another ophthalmic clinical trial within the past 30 days
- •Co-existing conditions that could interfere with the assessment of safety or efficacy of treatment (e.g. macular disease, pregnancy, nursing, etc.)
研究组 & 干预措施
TearCare
Subjects will receive a 12-minute treatment session with the TearCare System followed by manual expression of the meibomian glands. This procedure will be performed at the Baseline visit.
干预措施: TearCare (Device)
Warm Compress
Subjects will apply a warm compress to the eyelids for 5 minutes daily for 4 weeks.
干预措施: Warm Compress (Device)
结局指标
主要结局
Mean Change in Tear Breakup Time From Baseline to Month 1
时间窗: 4 weeks
The TBUT was evaluated by measuring the time to breakup of the tear film following a complete blink when viewed through the slit-lamp using a cobalt blue filter. The TBUT was recorded using a stopwatch for each eye as the average of 3 measurements at each visit. The change in TBUT was The difference between the mean baseline value and the mean Month 1 value. The TBUT for each eye for a subject was averaged. An increase in TBUT represents an improvement.
次要结局
- Mean Change in Meibomian Gland Score From Baseline to Month 1(1 month)
- Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score From Baseline(1 Month)
- Mean Change in OSDI Score From Baseline to Month 1(1 Month)
- Mean Change in SANDE ( Symptom Assessment in Dry Eye) Questionnaire Score From Baseline to Month 1(1 Month)