A Single-Center, Double-Masked, Randomized Study Evaluating the Tolerability and Efficacy of CWT-f-002 Lubricant Eye Drops Compared to Systane® Preservative-Free Eye Drops in the Treatment of the Signs and Symptoms of Dry Eye Disease (DED)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Tear Film Break-up Time
研究概览
简要总结
The primary objective is to evaluate the tolerability and efficacy of CWT-f-002 lubricant eye drops in the treatment of the signs and symptoms of dry eye disease.
详细描述
In this study CWT-f-002 lubricant eye drop is being evaluated in subjects with dry eye. This OTC eye drop has previously shown promising results in multiple preclinical and clinical settings. The active comparator for this study is Systane (R). Ingredient lists as follows. CWT-f-002: Active Ingredients are glycerin 0.7% and polyethylene glycol 400 0.4%. Inactive ingredients are mannitol, polylysine-graft-polyethylene glycol, sterile water for injection, and sodium phosphate buffer. Systane: Active ingredients are polyethylene glycol 400 0.4% and propylene glycol 0.3%. Inactive ingredients are boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, potassium chloride, purified water, sodium chloride, zinc chloride. Systane (R) may contain hydrochloric acid and/or sodium hydroxide to adjust pH. Both products are preservative free and supplied in unit dosers.
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 (Participant, Investigator)
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
- •Be at least 18 years of age
- •Have a reported history of dry eye for at least 6 months
- •Have a Tear Film Breakup Time (TFBUT) measurement of >1 and <7 seconds at Visit 1
排除标准
- •Known contraindications or sensitivities to the use of the study treatment or any of its components
- •Have a clinically significant slit lamp finding at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters
- •Have a condition (ocular or systemic) that the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the trial
研究组 & 干预措施
glycerin 0.7%/PEG 400 0.3%
20 patients will receive glycerin 0.7%/PEG 400 0.3% lubricant eye drops three times per day for 28 days.
干预措施: glycerin 0.7%/PEG 400 0.3% (Drug)
polyethylene glycol 400 0.4%/propylene glycol 0.3%
10 patients will receive polyethylene glycol 400 0.4%/propylene glycol 0.3% lubricant eye drops three times per day for 28 days.
干预措施: polyethylene glycol 400 0.4%/propylene glycol 0.3% (Drug)
结局指标
主要结局
Tear Film Break-up Time
时间窗: 15 minutes after eye drop instillation
State-of-the-art methodology to assess tear stability.
次要结局
未报告次要终点