Pilot Study of TearCare System - Long-Term Extension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Mean Change in Tear Break-Up Time From Extension Study Baseline to Month 1
研究概览
简要总结
The objective of the study is to evaluate the long-term clinical utility, safety, and effectiveness of re-treatment with the TearCare™ System in adult patients with dry eye syndrome who had previously been treated with the TearCare System.
详细描述
This was an extension of an initial 6-month, prospective, single-center, randomized, parallel-group pilot study (NCT03006978). In the initial study, subjects with dry eye disease (DED) were randomized to either a single TearCare® treatment or 4 weeks of daily warm compress therapy. The extension study involved retreatment of those subjects assigned to the TearCare® treatment group following the initial 6-month end point. At 6 months, subjects were evaluated for the clinical signs and symptoms of DED prior to retreatment in the extension study that would measure the safety, effectiveness, and durability of a TearCare® retreatment for another 6 months through a 12-month end point.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously enrolled in the TearCare arm of the TearCare Pilot Study
- •Reports dry eye symptoms within 3 months of the baseline examination with a Standard Patient Evaluation for Dryness (SPEED) score ≥ 6
- •TBUT of <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 one TearCare treatment at the baseline visit
干预措施: TearCare (Device)
结局指标
主要结局
Mean Change in Tear Break-Up Time From Extension Study Baseline to Month 1
时间窗: 1 month
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 resulting in a single TBUT value for each subject (n=12).
次要结局
- Mean Change in SANDE Result From Extension Study Baseline to Month 1(1 month)
- Mean Change in Meibomian Gland Score From Extension Study Baseline to Month 1(1 month)
- Mean Change in SPEED II Questionnaire Result From Extension Study Baseline to Month 1(1 month)
- Mean Change in OSDI Questionnaire Result From Extension Study Baseline to Month 1.(1 month)
- Mean Change in Corneal Staining From Extension Study Baseline to Month 1(1 month)
- Mean Change in Conjunctival Staining From Extension Study Baseline to Month 1(1 month)