Hydroxypropyl-methylcellulose and GlicoPro® Eyedrops in the Treatment of Dry Eye Disease: Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Ocular Surface Disease Index (OSDI) overall treatment effect
研究概览
简要总结
The goal of this clinical trial is to learn if Hydroxypropyl-methylcellulose and GlicoPro® eyedrops work to treat mild-to-moderate dry eye disease in adult patients. The main questions it aims to answer are:
Do Hydroxypropyl-methylcellulose and GlicoPro® eyedrops reduce patients' symptoms? Do Hydroxypropyl-methylcellulose and GlicoPro® eyedrops increase patients' tear film stability? Researchers will compare Hydroxypropyl-methylcellulose and GlicoPro® eyedrops to Hydroxypropyl-methylcellulose without GlicoPro® eyedrops to see if Hydroxypropyl-methylcellulose and GlicoPro® formulation works better to treat dry eye..
Participants will
- Take Hydroxypropyl-methylcellulose and GlicoPro® eyedrops or Hydroxypropyl-methylcellulose eyedrops every day for 3 months
- Visit the clinic 3 times in 3 months for checkups and tests
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
- Single (Outcomes Assessor)
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
- •Age >18 years
- •Ocular Surface Disease Index (OSDI) >12 AND <65
- •Fluorescein breakup time (FBUT) <10 seconds OR (Oxford staining Score >1 AND <4).
排除标准
- •Systemic or ocular diseases with known effect on tear film and ocular surface
- •Systemic or ocular medications with known effect on tear film and ocular surface
- •Contact lens wearing,
- •Ocular surgery in the 12 months before enrollment
- •Known allergy or poor tolerance to any ingredient of the study products
- •Presumed poor compliance to study procedures.
结局指标
主要结局
Ocular Surface Disease Index (OSDI) overall treatment effect
时间窗: From enrollment to the end of treatment at 3 months
OSDI is a standardized questionnaire for dry eye symptoms (Schiffman RM, et al. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. ). OSDI overall treatment effect (Month 1 and Month 3)
Symptom Assessment iN Dry Eye (SANDE) overall treatment effect
时间窗: From enrollment to the end of treatment at 3 months
SANDE is a validated short global dry eye symptom index (Schaumberg DA, et al. Development and validation of a short global dry eye symptom index. Ocul Surf. 2007 Jan;5(1):50-7) SANDE overall treatment effect (Month 1 and Month 3)
Fluorescein Break-up time (FBUT) overall treatment effect
时间窗: From enrollment to the end of treatment at 3 months
FBUT is a widely used method to assess tear film stability (Wolffsohn JS, et al. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017 Jul;15(3):539-574. ) FBUT overall treatment effect (Month 1 and Month 3).
次要结局
未报告次要终点
研究者
Edoardo Villani
Associate professor of ophthalmology
University of Milan