NCT01014078已完成4 期
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease
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
- 112
- 试验地点
- 9
- 主要终点
- Tear Break-Up Time (TBUT)
研究概览
简要总结
The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% in dry eye subjects over a four week treatment period, using placebo as a comparison.
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
- •Have a current diagnosis of dry eye in one or both eyes
- •Moderate to severe degree of meibomian gland plugging
- •Have best corrected visual acuity in both eyes of at least +0.7 LogMAR
- •If female, are non-pregnant or non-lactating
排除标准
- •Have anterior blepharitis
- •Have lid structural abnormalities
- •Have suspected ocular fungal or viral infection
- •Have had penetrating intraocular surgery in the past 90 days or require penetrating intraocular surgery during the study
- •Have had ocular surface surgery [e.g., laser-assisted in situ keratomileusis (LASIK), refractive, pterygium] within the past year.
- •Unable to withhold the use of contact lenses during the study
- •Have a known hypersensitivity to azithromycin, erythromycin, any other macrolide antibiotic, or any of the other ingredients in the study medication.
- •Have a history of post vitreous detachment.
- •Are considered legally blind in 1 eye (LogMAR BCVA= 1.0 or Snellen BCVA= 20/200).
- •Have permanent conjunctival goblet cell loss or scarring conditions, including cicatricial blepharitis or conjunctivitis.
- •Have a congenitally absent meibomian gland or lacrimal gland.
- •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 a serious medical condition which would confound study assessments.
- •Have a concomitant ocular pathology that, in the opinion of the investigator, may confound study assessments.
研究组 & 干预措施
Azithromycin Ophthalmic Solution, 1%
Experimental
干预措施: Azithromycin Ophthalmic Solution, 1% (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Tear Break-Up Time (TBUT)
时间窗: 4 weeks
次要结局
- Corneal Staining(4 weeks)
- Tear Volume(4 weeks)
- Meibomian gland plugging(4 weeks)
- Subject-rated scores of dry eye symptoms(4 weeks)
研究者
研究点 (9)
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