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.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported dry eye symptoms
- •Tear Break Up Time of less than 10 seconds as assessed by the Oculus Keratograph (see Appendix A).
- •SPEED II Score greater than 25
- •Men or Women, age between 50 and 90 inclusive
- •Willingness to undergo both pre-treatment and post-treatment testing per the protocol
- •Willingness to endure the 2-3 hour time required to place eyelash extensions, if randomized to this treatment arm
- •Willingness to use eye drops for dry eyes and fill a prescription through insurance coverage, if randomized to this treatment arm
- •Willingness to attend all study visits
- •Willingness to sign informed consent and liability waiver
排除标准
- •Absence of eyelashes
- •Eyelash disease such as clinically significiant demodex, blepharitis, meibomitis
- •Be unable or unwilling to give written informed consent and/or to comply with study procedures.
- •Have any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes.
- •Be unable to demonstrate correct instillation of over the counter (OTC) ocular lubricant during Visit
- •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.
- •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
- •Current use of Restasis or Xiidra at the time of Visit 1
- •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.
- •Any history of Herpes simplex of Herpes zoster affecting the eye or head.
研究组 & 干预措施
Eyelash Prostheses
Each subject in this arm will receive eyelash prostheses according to a specified algorithm by a certified eyelash extensions.
干预措施: Eyelash prostheses (Device)
5.0% Lifitegrast Ophthalmic Solution
Each subject in this arm will receive 5.0% Lifitegrast eye drops BID
干预措施: 5.0% Lifitegrast Ophthalmic Solution (Device)
结局指标
主要结局
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
时间窗: 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
次要结局
- Non-inferior change in tear meniscus height as measured by the Oculus Keratograph in the treatment subjects compared to control subjects(The secondary endpoint will be assessed 3 weeks after eyelash prosthesis placement in the interventional arm and the interventional arm and 5 weeks after initiation of eye drops in the active comparator arm)
- Non-inferior change from baseline in SPEED II questionnaire in the treatment subjects compared to the control subjects(The secondary endpoint will be assessed 3 weeks after eyelash prosthesis placement in the interventional arm and the interventional arm and 5 weeks after initiation of eye drops in the active comparator arm)