CTRI/2017/08/009210尚未招募未知
A Multi-Centeric, Open-Label, Randomized, Cross-over, Aqueous Humor Bioequivalence Study of Loteprednol Etabonate Ophthalmic Suspension 0.5% (Sun Pharmaceutical Industries, Ltd.) and Lotemax® (Loteprednol Etabonate Ophthalmic Suspension 0.5%; Bausch & Lamb, Inc.) in Subjects With Indicated Bilateral Cataract Surgery
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 418
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1.Willing and able to provide written informed consent prior to any study procedures being performed.
- •2. Ready and able to follow all instructions and attend all study visits.
- •3.Have planned bilateral cataract extraction
- •4. Agree to perform pregnancy test before participation in the trial
- •5.Agree to use an acceptable method of contraception for the duration of the study or not be of childbearing potential.
排除标准
- •1.Have any active ocular disease in either eye that requires prescription treatment
- •2.Have an active infection (bacterial, viral or fungal) of either eye or eyelids
- •3.Pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test.
- •4.use of an investigational drug or device within 30 days of Visit 1.
研究者
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