NCT00901693终止2 期
An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 452
- 主要终点
- Sustained microbiological success at Day 5 or Day 7
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of AL-46383A Ophthalmic Solution for the treatment of adenoviral conjunctivitis.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one eye must have EITHER a positive adenovirus test (using the Adeno Detector™ for Adenoviral Conjunctivitis, Rapid Pathogen Screening, Inc.) OR a positive clinical diagnosis assessed by the Adenoviral Clinical Diagnostic Checklist.
- •Onset and development of ocular symptoms and/or signs of conjunctivitis ≤ 7 days prior to enrollment (Day 1) in either eye.
- •Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/ Independent Ethics Committee (IRB/IEC).
- •Must agree to comply with the visit schedule and other requirements of the study.
- •Females who are not pregnant and are not lactating. All females of childbearing potential (those who are not pre-menarcheal, not postmenopausal or surgically sterile) may participate only if they have a negative urine pregnancy test prior to randomization, and if they agree to use adequate birth control methods to prevent pregnancy throughout the study.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Sub-epithelial infiltrates at the Day 1 visit in either eye.
- •Corneal opacity or any corneal abnormality at the Day 1 visit in either eye.
- •Contact lens wear during the course of the study. Participants requiring correction must have spectacles with appropriate correction.
- •Only one sighted eye or vision in either eye not correctable to 0.6 or better logMAR (using ETDRS chart) at the Day 1 visit.
- •Abnormal findings in the posterior pole of the retina or any media opacity found in a dilated fundus examination at the Day 1 (Screening/ Baseline) visit.
- •Suspected fungal, herpes, Chlamydia or Acanthamoeba infection, based on clinical observation.
- •History of active uveitis or iritis in either eye.
- •History of corneal transplant in either eye.
- •Presence of nasolacrimal duct obstruction at Day
- •Use of specified prohibited medications.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AL-46383A
Experimental
AL-46383A Ophthalmic Solution, 1 drop in each eye, 8 times a day for 10 days
干预措施: AL-46383A Ophthalmic Solution (Drug)
Vehicle
Placebo Comparator
AL-46383A Ophthalmic Solution Vehicle, 1 drop in each eye, 8 times a day, for 10 days
干预措施: AL-46383A Ophthalmic Solution Vehicle (Drug)
结局指标
主要结局
Sustained microbiological success at Day 5 or Day 7
时间窗: Up to Day 18
次要结局
- Time to sustained microbiological success(Up to Day 18)
研究者
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