NCT06903741已完成不适用
Effect of a New Preservative-free Combination of Trehalose, Sodium Hyaluronate and N-acetyl-aspartyl-glutamate (NAAGA) on Dry Eye Disease and Patient Quality of Life
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Improvement of DED signs and symptoms at 6 months (M6) according to Ocular Surface Disease Index (OSDI) score change from baseline to M6
研究概览
简要总结
The goal of this prospective, non-randomized, non-comparative, monocentric PMCF study is to assess the performance of a new preservative-free combination of trehalose, sodium hyaluronate and NAAGA on DED at 6 months in 30 patients having dry eye disease.
The main questions it aims to answer are:
- To assess the performance and safety of T2769 at 3 months and 6 months.
- To assess patient compliance to therapy.
- To assess the occurrence of dry eye flares. Participants will be asked to use T2769 on a daily basis and complete a self-questionnaire throughout the study.
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
- •Men and women aged over 18 years,
- •Able to give written informed consent prior the initiation of any procedure,
- •Dry eye diagnosis and/or dry eye symptoms in the last 3 months,
- •OSDI >12,
- •Never been treated with artificial tears or with no artificial tears at least 1 month before the enrolment, or not satisfied with current artificial tears.
排除标准
- •Ophthalmic Exclusion Criteria in at least one eye •Far BCVA ≥+0.7 LogMAR (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 ETDRS letters).
- •Systemic/non Ophthalmic Exclusion Criteria
- •Known or suspected hypersensitivity to one of the components of the IMD,
- •History of or active relevant systemic condition incompatible with the investigation or likely to interfere with the investigation results or the patient safety according to investigator judgment.
- •Specific Exclusion Criteria Regarding Childbearing Potential Women
- •Pregnant or breast-feeding women,
- •Childbearing potential women neither surgically sterilised nor using an adequate contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch).
- •Exclusion Criteria Related to General Conditions
- •Alcohol addiction and heavy smoker according to investigator's judgement,
- •Unable to understand the investigation procedures or to give informed consent,
- •Non-compliant (e.g., not willing to attend a visit or completing the self-questionnaire; way of life interfering with compliance),
- •Participant in this investigation at the same time as another clinical investigation/study,
- •Participant in this investigation within the exclusion period of a previous study/investigation with a minimum of one month,
- •Participant being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee or family member of the investigation sites or of the Sponsor's company.
- •Exclusion criteria related to previous and concomitant treatments (medications/non-medicinal therapies/procedures)
- •Participant with previous, current or anticipated prohibited listed treatment (or prohibited modification of treatment regimen).
研究组 & 干预措施
Treated group
Experimental
Groupe receiving T2769
干预措施: T2769 (Device)
结局指标
主要结局
Improvement of DED signs and symptoms at 6 months (M6) according to Ocular Surface Disease Index (OSDI) score change from baseline to M6
时间窗: at baseline, at 3 months, at 6 months
Improvement of DED signs and symptoms at 6 months (M6) according to Ocular Surface Disease Index (OSDI) score change from baseline to M6 OSDI is a 12-item scale with total score from 0 to 100 (Mild 13-22; moderate 23-32; severe 33-100)
次要结局
未报告次要终点
研究者
研究点 (3)
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