NCT00357201已完成2 期
Evaluation of the Efficacy of T1675, a Per Os Omega 3 and Omega 6 Polyunsaturated Essential Fatty Acid Dietary Formulation Versus Placebo in Patients With Bilateral Treated Moderate Dry Eye Syndrome
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 主要终点
- Total score of the lissamine green staining test in the right eye on Day 168 (Month 6).
研究概览
简要总结
To evaluate the efficacy of a 6-month (± 14 days) dietary supplementation period with T1675, a per os omega 3 and omega 6 polyunsaturated essential fatty acid dietary formulation, versus placebo in patients with bilateral treated moderate dry eye syndrome
详细描述
The aim of the present study is to evaluate the efficacy of a 6-month (± 14 days) dietary supplementation period with T1675 versus placebo in patients with bilateral moderate dry eye syndrome already treated with tear substitutes, and to point out, through several parameters, the best efficacy parameter that could be used for a future clinical phase III study.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent.
- •Male or female aged from 18 to 90 years old.
- •Known treated bilateral dry eye.
- •Dry eye syndrome confirmed by ocular examination with a fluorescein and/or lissamine green staining, BUT and Schirmer, performed within the last 12 months before Inclusion Visit, for both eyes.
- •Bilateral symptomatology suggestive of dry eye defined by: at least one of the following ocular symptoms suggestive of dry eye (burning, stinging, dryness feeling, sandy and/or gritty sensation, light sensitivity, reflex tearing, ocular fatigue) and Questioning on patient's feeling (score >=3).
- •Fulfilling the following criteria of dry eye syndrome in both eyes defined by: Keratoconjunctivitis defined by a lissamine green score ≥ 4 (Van Bijsterveld score) and Schirmer test <= 10 mm in 5 min or BUT < 10 s
排除标准
- •severe dry eye symptom
- •eyelid dysfunction
- •severe progressive rosacea
- •any relevant ocular anomaly interfering with ocular surface
- •best corrected far visual acuity <= 1/10
- •history of ocular allergy
- •traumatism, infection, inflammation within last 3 months
- •ocular surgery and laser within the last 3 months
- •lasik, laser, PKR within the last 12 months
- •contact lenses
- •any concomitant nutritive supplementation, vitamins
- •any topical concomitant treatment
结局指标
主要结局
Total score of the lissamine green staining test in the right eye on Day 168 (Month 6).
次要结局
- Total score of the lissamine green staining test in the right eye on Day 0, Day 28 (Month 1), Day 84 (Month 3), Month 12, Month 18, Month 24, Month 30, and Month 36
- Global efficacy
- Tolerance
研究者
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