NCT01175590已完成3 期
A Study to Evaluate the Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle Following Three Times Daily(TID) Dosing for 7 Days
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 518
- 试验地点
- 1
- 主要终点
- Ocular Treatment Emergent Adverse Events
研究概览
简要总结
The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye.
- •Subjects who are willing to discontinue contact lens wear for the duration of the study.
- •Subjects who are able and willing to comply with all treatment and follow- up/study procedures.
排除标准
- •Subjects who have any uncontrolled systemic disease or debilitating disease.
- •Subjects with a known hypersensitivity or contraindications to Besivance, fluoroquinolones, or any of the ingredients in the study drugs.
- •Subjects who are expected to require disallowed concurrent systemic or ocular therapy(either eye)during or prior to study start. (ie, NSAIDs, corticosteroids, mast cell stabilizers, antihistamines, decongestants or antimicrobial therapy)
- •Subjects having ocular surgery (including laser surgery) in either eye within six weeks prior to entry into this study.
- •Subjects with suspected viral or allergic conjunctivitis or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication.
- •Subjects with suspected iritis.
- •Subjects with a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome.
- •Subjects with any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis.
- •Subjects who are immune compromised.
研究组 & 干预措施
Besivance
Experimental
besifloxacin ophthalmic suspension 0.6%
干预措施: Besivance (Drug)
Vehicle
Placebo Comparator
Vehicle of Besivance
干预措施: Vehicle (Drug)
结局指标
主要结局
Ocular Treatment Emergent Adverse Events
时间窗: At each visit - 7 days
Ocular Treatment-Emergent Adverse Events on the Study Eye
Non-Ocular Treatment-Emergent Adverse Events
时间窗: 7 days
Non-Ocular Treatment-Emergent Adverse Events on the Study Eye
次要结局
- Clinical Resolution(Day 11 (Visit 3))
- Microbial Eradication(Days 11 (Visit 3))
- Microbial Outcome With Clinical Resolution(Day 11 (Visit 3))
- Individual Clinical Outcomes - Ocular Discharge(At day 11 (Vist 3))
- Individual Clinical Outcomes - Bulbar Injection(At day 11 (Vist 3))
研究者
研究点 (1)
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