Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Texas
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Fort Worth、Texas、美国、76134
- Contact Alcon Call Center for Trial Locations
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Vigamox
Vigamox Ophthalmic Solution (Moxifloxacin 5mg/mL)
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Moxifloxacin 5mg/mL 3 times daily for 7 days
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安慰剂比较:BSS Placebo
Balanced Salt Solution
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Balanced Saline Solution for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Exploratory Outcomes From Digital Photography
大体时间:24 hours after administration of first dose
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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.
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24 hours after administration of first dose
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Exploratory Evaluation of Changes in Ocular Signs and Symptoms
大体时间:Baseline (Day 1) to Day 2
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Number of patients who had clinical resolution (0 on all scales below) from baseline (Day 1) to Day 2 in ocular and symptoms of bacterial conjunctivitis: Bulbar Conjunctival Injection - 0 (none) to 4 (Severe) scale. Conjunctival Discharge (Mucopurulent) - 0 (none) to 3 (Severe) scale. Lid Erythema - 0 (none) to 3 (Severe) scale. Lid Swelling - 0 (none) to 3 (Severe) scale. Palpebral Conjunctiva - 0 (none) to 3 (Severe) scale. Foreign Body Sensation - 0 (none) to 3 (Severe) scale. Tearing - 0 (none) to 3 (Severe) scale. Photophobia - 0 (none) to 3 (Severe) scale. |
Baseline (Day 1) to Day 2
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Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans
大体时间:24 hours after administration of first dose
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Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
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24 hours after administration of first dose
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Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like
大体时间:24 hour after administration of first dose
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Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
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24 hour after administration of first dose
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Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae
大体时间:24 hours after administration of first dose
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Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
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24 hours after administration of first dose
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Vigamox Ophthalmic Solution的临床试验
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University of Zurich招聘中