jRCT1080222777未知2 期
XED-60 in the treatment of dry eye, Phase2 study.
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 主要终点
- dry eye symptom score (dryness)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Phase2 Study
入排标准
- 年龄范围
- 15age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1) Males or Females
- •(2) 15years old or older
- •(3) Out patient
- •(4) Meet the diagnostic criteria (Definition and Diagnosis of Dry Eye 2006) of the Japanese Dry Eye Research group
- •(5) Dryness score of dry eye-related ocular symptoms 2 point or over
排除标准
- •(1) Stevens-Johnson syndrome and ocular pemphigoid
- •(2) Chemical or thermal burns
- •(3) Other ocular diseases
- •(4) Allogeneic heamatopoietic stem cell transplantation
- •(5) Any history of ocular surgery within 3 months
- •(6) Refractive corneal surgery
- •(7) Patient with punctal plug
- •(8) Female patients who are pregnant, possibly pregnant or breast feeding
- •(9) Known hypersensitivity to any component of the study drug or procedual medications
- •(10) Glaucoma patient
- •(11) Anticipated use of contact lens during the study
- •(12) Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
- •(13) Any systemic disease
结局指标
主要结局
dry eye symptom score (dryness)
时间窗: 4-week endpoint (last observation carried forward)
The change in dry eye symptom score (dryness) from baseline
fluorescein staining scores
时间窗: 4-week endpoint (last observation carried forward)
The change in fluorescein staining scores from baseline
rose bengal staining scores
时间窗: 4-week endpoint (last observation carried forward)
The change in rose bengal staining scores from baseline
次要结局
- subjective dry eye symptom score(from baseline at the 4-week endpoint (last observation carried forward))
研究者
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