NCT00798577已完成4 期
Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Exploratory Outcomes From Digital Photography
研究概览
简要总结
The primary objective of this study is to investigate the initial antibiotic effects in the treatment of bacterial conjunctivitis symptoms in subjects one year of age and older.
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
- •Diagnosis in one or both eyes of bacterial conjunctivitis based on:
- •symptoms less than or equal to 24 hours prior to first visit
- •rating > or equal to 1 for bulbar conjunctival injection
- •must have a rating > 1 for conjunctival discharge / exudate in at least one eye (the same eye as bulbar conjunctival injection ) at Visit 1, and
- •Must experience some matting in the affected eye(s).
- •1 year of age or older, of any race and either sex
- •Able to understand and sign an informed consent that has been approved by an Institutional Review Board; or if the subject is a minor, the informed consent must be signed and understood by the subjects legally authorized representative (parent or guardian). Assent to participate should be obtained from subjects 6 years of age or older unless not allowed by local regulation.
- •Must agree to comply with study visit schedule, photographs and other study requirements. If subject is a minor, the parent or guardian must agree to ensure compliance.
排除标准
- •Cannot have had bacterial conjunctivitis as reported by subject (or parent if subject is a minor) for > 24 hours.
- •Any current lid disease on clinical examination.
- •Known or suspected allergy or hypersensitivity to fluoroquinolones.
- •Suspected fungal, viral (e.g. Herpes simplex) or Acanthamoeba infection, based on clinical observation.
- •Any systemic or ocular disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study (e.g., hepatitis, acute or chronic renal insufficiency).
- •Use of topical ocular medications during the study period.
- •Antibiotics (systemic or topical) may not be used within 7 day of visit 1 or anytime after this visit for the duration of the study.
- •Women of childbearing potential not using reliable means of birth control.
- •Women who are pregnant or lactating.
- •Enrollment of more than one person per household at the same time.
- •Enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
- •Participation in any investigational drug or device study within 30 days of entering this study.
研究组 & 干预措施
Vigamox
Experimental
Vigamox Ophthalmic Solution (Moxifloxacin 5mg/mL)
干预措施: Vigamox Ophthalmic Solution (Drug)
BSS Placebo
Placebo Comparator
Balanced Salt Solution
干预措施: BSS placebo (Drug)
结局指标
主要结局
Exploratory Outcomes From Digital Photography
时间窗: 24 hours after administration of first dose
Photographs were taken before and after treatment. Outcome is the number of patients whose photographs showed a subjective visual change based upon an exploratory review of patient photographs in signs of bacterial conjunctivitis before and after treatment.
次要结局
- Exploratory Evaluation of Changes in Ocular Signs and Symptoms(Baseline (Day 1) to Day 2)
- Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans(24 hours after administration of first dose)
- Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like(24 hour after administration of first dose)
- Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae(24 hours after administration of first dose)
研究者
研究点 (1)
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