Eyelash Prostheses Compared to 5.0% Lifitegrast BID for Dry Eye Disease.
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D.E.L., LLC
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 28, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | October 2, 2018 | ||
| 预计主要完成日期 | April 2, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Non-inferior change from baseline in tear break up time as measured by the Oculus Keratograph in the interventional subjects compared to the active control subjects[ Time Frame: The primary endpoint will be assessed 3 weeks after eyelash prosthesis placement in the interventional arm and 5 weeks after initiation of eye drops in the active comparator arm ] A non-inferiority endpoint in tear break up time |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Eyelash Prostheses Compared to 5.0% Lifitegrast BID for Dry Eye Disease. | ||
| 正式标题 ICMJE | A Single Center, Randomized, Controlled Trial Evaluating the Efficacy and Safety of Eyelash Prostheses Compared to 5.0% Lifitegrast Ophthalmic Solution in Subjects With Dry Eye Disease. | ||
| 简要概况 | This is a single-center, randomized, controlled trial to evaluate the safety and efficacy of eyelash prostheses versus 5.0% Lifitegrast BID, in 40 patients (20 randomized to each of two arms of the study) evaluated at 3 weeks and 5 weeks, respectively, after initiation of treatment. |
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| 详细说明 | This is a single center, randomized, controlled clinical trial to evaluate the tolerability, efficacy, and safety of eyelash prostheses over a 3-week period versus Xiidra BID over a 5 week period in subjects with self-reported DED. 40 subjects will be randomized to either eyelash prostheses or Xiidra, in a 1:1 ratio. At Visit 1 (screening), informed consent will be obtained from subjects and eligibility will then be determined. All pre-treatment assessments will be done at this visit. Randomization will occur. If randomized to receive Xiidra eye drops, a prescription will be written and the treatment will be started right away. If randomized to eyelash prostheses, then a second study visit will be made approximately 2 weeks later. Visit 2 (Eyelash Prostheses application) Subjects randomized to receive eyelash prostheses will have them applied approximately 2 weeks after the screening and randomization visit. Visit 3 (Final visit) will be 3 weeks post eyelash prosthesis placement and 5 weeks post Xiidra eye drop initiation. This was done to compare the maximal treatment effect between the two groups. All subjects will undergo post-treatment assessments. At each visit, patients will be asked to report any adverse events. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: Prospective randomized clinical trial 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
40 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | May 1, 2019 | ||
| 预计主要完成日期 | April 2, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Self-reported dry eye symptoms 2. Tear Break Up Time of less than 10 seconds as assessed by the Oculus Keratograph (see Appendix A). 3. SPEED II Score greater than 25 4. Men or Women, age between 50 and 90 inclusive 5. Willingness to undergo both pre-treatment and post-treatment testing per the protocol 6. Willingness to endure the 2-3 hour time required to place eyelash extensions, if randomized to this treatment arm 7. Willingness to use eye drops for dry eyes and fill a prescription through insurance coverage, if randomized to this treatment arm 8. Willingness to attend all study visits 9. Willingness to sign informed consent and liability waiver Exclusion Criteria: 1. Absence of eyelashes 2. Eyelash disease such as clinically significiant demodex, blepharitis, meibomitis 3. Be unable or unwilling to give written informed consent and/or to comply with study procedures. 4. Have any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes. 5. Be unable to demonstrate correct instillation of over the counter (OTC) ocular lubricant during Visit 1. 6. Have clinically significant ocular surface disease in either eye (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with study safety procedures, or assessments. 7. Have clinically significant systemic disease (e.g., uncontrolled diabetes, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study at Visit 1 and 2. 8. Current use of Restasis or Xiidra at the time of Visit 1 9. Changes in the dose of, or the initiation of, any medications that are known to affect dry eyes within 90 days of Visit 1 or during the duration of the study. 10. Any history of Herpes simplex of Herpes zoster affecting the eye or head. | ||
| 性别 |
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| 年龄 | 最小年龄：50 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: Yes |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | D.E.L., LLC | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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