NCT01437982已完成4 期
A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%
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
- 140
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
The objective of this study is to identify any adverse events or adverse drug reactions through post-marketing surveillance under routine clinical practice
详细描述
The objective of this study is to identify any adverse events or adverse drug reactions through post-marketing surveillance under routine clinical practice after marketing authorization of Lotemax ophthalmic suspension 0.5%
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have been treated with the study drug at least once and completed safety follow-up.
- •Subjects who have been treated with the study drug at least once and completed the clinical efficacy assessment.
排除标准
- •Subjects not treated with study drug at least once.
研究组 & 干预措施
Loteprednol Etabonate
Experimental
Ophthalmic Gel 0.5%
干预措施: Loteprednol Etabonate (Drug)
Prednisolone Acetate 1% Oph Susp
Experimental
Ophthalmic suspension 0.5%
干预措施: Prednisolone Acetate 1% Oph Susp (Drug)
结局指标
主要结局
Safety
时间窗: 4 years
All adverse events that occurred from the first dose of the study drug regardless of causality to the study drug. Changes in all undesirable medical findings and all adverse events occurring with the use of the study drug.
次要结局
- Giant Papillary Conjunctivitis(4 years)
- Seasonal Allergic Conjunctivitis(4 years)
- Post-operative inflammation(4 years)
研究者
研究点 (1)
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