NCT01105624已完成4 期
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Rewetting Drops in Subjects With History and Current Complaint of Contact Lens-Related Dry Eye (CLDE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint
研究概览
简要总结
The primary objective of this study is to compare the duration of subject reported comfortable contact lens daily wear time in subjects with a history and current complaint of CLDE during a 29-day treatment period of azithromycin ophthalmic solution, 1%, compared to rewetting drops
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
- 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
- •Have a history of and current complaint of CLDE.
- •Use properly fitted daily-wear soft contact lenses.
- •Able to wear contact lenses for at least 8 hours a day.
- •If female, are non-pregnant or non-lactating.
排除标准
- •Have changed brand of contact lens or care solutions within one month prior to Visit
- •Use extended (overnight) wear contact lenses.
- •Have a clinically significant ophthalmic abnormality.
- •Have had cauterization of the punctum or have had punctal plugs (silicone or collagen) inserted or removed within the 90 days prior to the screening.
- •Have any active ongoing ocular infection or ocular disease.
- •Have a serious medical condition which could confound study assessments.
研究组 & 干预措施
azithromycin ophthalmic solution, 1%
Experimental
干预措施: azithromycin ophthalmic solution, 1% (Drug)
rewetting drops
Experimental
干预措施: Visine® for Contacts® (Drug)
结局指标
主要结局
Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint
时间窗: 4 weeks
次要结局
- Subject-reported comfortable contact lens daily wear time, excluding Week 4 Endpoint(2 weeks)
- Subject-reported duration of total contact lens daily wear(4 weeks)
- Subject-reported rating of overall eye dryness(4 weeks)
- Contact Lens-Related Dry Eye Questionnaire(4 weeks)
- Tear hyperosmolarity (mOsm)(4 weeks)
- Habitual low-contrast visual acuity (LCVA)(4 weeks)
研究者
研究点 (1)
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