Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 6
- 主要终点
- Change From Baseline in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Total Score.
研究概览
简要总结
This is a confirmatory clinical investigation. The objective is to collect new additional clinical data demonstrating the safety and performance of the device in the contact-lens wearing population with dry eyes. The hypotheses are that T2769 improves dry eye symptomatology (e.g. decrease in CLDEQ-8 score, in OSDI score, ocular discomfort assessed by VAS) and signs (e.g. increase in Schirmer and TBUT, decrease in Oxford score) at D36, in comparison to baseline.
The primary objective of this investigation is to assess the performance of T2769 in contact lens wearers with dry eye symptoms in terms of change from baseline (Day 1) to Day 36 (Final visit) in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score.
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
- •Informed consent signed and dated
- •Patient aged ≥ 18 years old
- •Well fitted contact lenses (CL) according to the investigator judgement
- •Daily wearer of any type of CL for a minimum of 5 days/week for 6 hours/day over at least the last month and is willing to continue to do so during the study
- •Patient with an Ocular Surface Disease Index (OSDI) score ≥ 18
- •CLDEQ-8 score ≥ 12
排除标准
- •Far Best-Corrected Visual Acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 ETDRS letters).
- •Severe blepharitis
- •Severe Meibomian gland dysfunction
- •Palpebral or nasolacrimal disorders
- •Dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia, Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract, Retinal disease.
结局指标
主要结局
Change From Baseline in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Total Score.
时间窗: CLDEQ- score is assessed at Day 1 and Day 36
The primary endpoint is the change from baseline (Day 1) to Day 36 in the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score. CLDEQ-8 consists of 8 questions designed to measure dry eye symptoms specifically related to the use of contact lenses. The total score is obtained by adding the scores obtained for each answer. The final score is ranging from 1 to 37. 37 is the worst score.
次要结局
未报告次要终点