NCT01381731终止2 期
A Double-masked, Randomized, Placebo-controlled,Pilot Study of Diquafosol Tetrasodium in Subjects Following Photorefractive Keratectomy (PRK)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 主要终点
- Healing time
研究概览
简要总结
The objectives of this trial are to:
- Assess the safety and tolerability of diquafosol tetrasodium ophthalmic solution versus placebo following one week of treatment in subjects undergoing photorefractive keratectomy (PRK).
- Evaluate the potential of diquafosol to accelerate corneal wound healing/re-epithelialization following PRK.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between age 18 - 45 years old
- •candidate for bilateral PRK
排除标准
- •dry eye disease
- •any corneal pathologies
- •previous corneal or intraocular surgeries
研究组 & 干预措施
Diquafosol tetrasodium ophthalmic solution 2%
Experimental
topical ophthalmic solution
干预措施: diquafosol tetrasodium ophthalmic solution 2% (Drug)
Placebo
Placebo Comparator
saline ophthalmic solution
干预措施: placebo (Drug)
结局指标
主要结局
Healing time
时间窗: 12 weeks
次要结局
- Adverse events(12 weeks)
研究者
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