NCT05741398招募中不适用
Evaluation of the Efficacy and Safety of Optical System in the Treatment of - Dry Eye Disease (DED) Pilot Study
Demaod Ltd2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- 4 weeks TBUT change from baseline
研究概览
简要总结
Single-center, Prospective, Open Label, with Before-After Study Design, to evaluate the safety and efficacy of the optical system in the treatment of dry eye disease.
详细描述
Single-center, Prospective, Open Label, with Before-After Study Design. Up to 15 subjects will be enrolled in the study to provide at least 10 evaluable subjects.
All subjects will undergo 3 treatments two weeks apart (2 weeks (+/-3 days) from the previous treatment).
Follow-up visits after the last treatment visit: 4 weeks (±7 days), 12 weeks (±7 days).
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
盲法说明
no masking during this study.
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older of any gender or race.
- •Provide written informed consent before study participation.
- •Willingness and ability to return for all study visits.
- •Ocular Surface Disease Index (OSDI) questionnaire and a score of ≥ 23 at the baseline visit.
- •Tear break-up time (TBUT) <10 seconds in both eyes.
- •Agreement/ability to abstain from dry eye/MGD medications for the time between the treatment visit/s and the final study visit. Ocular lubricants are allowed if no changes are made during the study.
排除标准
- •History of ocular surgery including intraocular, oculoplastic, corneal or refractive surgery within 1 year.
- •Patients with giant papillary conjunctivitis.
- •Patients with punctal plugs or who have had punctal cautery.
- •Ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination.
- •Active ocular herpes zoster or simplex of eye or eyelid or a history of these within the last 3 months.
- •Aphakic Patients.
- •Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
- •Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye).
- •Active ocular inflammation or history of chronic, recurrent ocular inflammation within 3 months (e.g., retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis).
结局指标
主要结局
4 weeks TBUT change from baseline
时间窗: up to 4 weeks post last treatment
Change from baseline to the 4-week follow-up exam in Tear Break Up Times (TBUT), as assessed by a rater.
次要结局
- OSDI changes from baseline to 4 and 12 weeks FU(up to 12 weeks post last treatment)
- 12 weeks TBUT change from baseline(12 weeks post last treatment)
研究者
研究点 (2)
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