NCT01408082已完成3 期
A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical Efficacy and Safety of ISV-502 Compared to AzaSite Alone, Dexamethasone Alone, and Vehicle in the Treatment of Subjects With Non-Bacterial Blepharitis
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
- 917
- 试验地点
- 41
- 主要终点
- Clinical Resolution
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502 compared to AzaSite® alone, Dexamethasone alone, and vehicle in the treatment of subjects with Non-bacterial Blepharitis.
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
- •Are at least 18 years of age at Visit 1 (Day 1, Baseline) of either sex and any race.
- •Signature of the subject or legally authorized representative on the Informed Consent Form.
- •Are willing and able to follow all instructions and attend all study visits.
- •Are willing to avoid disallowed medication for the duration of the study.
- •If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing. Post menopausal is defined as having no menses for at least 12 consecutive months.
- •Additional inclusion criteria also apply.
排除标准
- •Have known sensitivity or poor tolerance to any component of the Investigational Drug.
- •Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation other than Blepharitis in the study eye.
- •Have used topical corticosteroid medications or topical ophthalmic solutions that the investigator feels may interfere with the study parameters.
- •Have used any non-diagnostic topical ophthalmic solutions in the study eye.
- •Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test.
- •Currently suffer from alcohol and/or drug abuse.
- •Have prior (within 30 days of beginning dosing) or anticipated concurrent use of an investigational drug or device.
- •Have a condition or a situation which, in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
- •Additional exclusion criteria also apply.
研究组 & 干预措施
ISV-502
Experimental
干预措施: ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined) (Drug)
AzaSite
Active Comparator
干预措施: Azasite (Drug)
Dexamethasone
Active Comparator
干预措施: Dexamethasone (Drug)
Vehicle
Placebo Comparator
干预措施: Vehicle (Other)
结局指标
主要结局
Clinical Resolution
时间窗: Day 15
The primary efficacy endpoint for the comparison of ISV-502 and AzaSite is complete clinical resolution of signs and symptoms at Day 15.
Recurrence of Clinical Signs and Symptoms
时间窗: 6 Month
The primary efficacy endpoint for the comparison of ISV-502 and Dexamethasone is recurrence of clinical signs and symptoms by 6-Month Follow-up.
次要结局
未报告次要终点
研究者
研究点 (41)
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