Efficacy and Safety of COL-101 for the Treatment of Blepharitis in Patients With Facial Rosacea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 70
- 试验地点
- 8
- 主要终点
- Change in Bulbar Conjunctival Hyperemia
研究概览
简要总结
To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •blepharitis
- •facial rosacea
排除标准
- •pregnant or nursing women
- •allergy to tetracyclines
- •recent eye surgery
- •past or current use of isotretinoin
- •patients who are achlorhydric
- •patients who have had gastric by-pass surgery
研究组 & 干预措施
COL-101 (doxycycline, USP) capsules
COL-101
干预措施: COL-101 (doxycycline, USP) capsules (Drug)
Placebo
Sugar capsule
干预措施: placebo (Drug)
结局指标
主要结局
Change in Bulbar Conjunctival Hyperemia
时间窗: Baseline to Week 12
Bulbar conjunctival hyperemia will be assessed using an ordered categorical value ranging from 0 (Clear) to 4 (Severe). Hyperemia is graded on the following scale and half scores are acceptable: None (0) = normal Mild (1) = slight localized injection Moderate (2) = pink color Severe (3) = red color Very Severe (4) = marked dark redness
Change in Ocular Surface Disease Index (OSDI)
时间窗: Baseline to Week 12
OSDI is calculated based following formula using 12-question Ocular Surface Disease questionnaire (with each question scored 0-4): OSDI = (D/E)x25, where D = Sum of all scores for questions answered E = Total number of questions answered (not including questions answered NA) Range of OSDI is 0 to 100 (higher score indicates worse condition).
次要结局
未报告次要终点