CTRI/2009/091/000830已完成3 期
A Comparative, Randomized, Double Blind, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Lidocaine Hydrochloride Ophthalmic Gel 3.5% Vs Akten in patients for ocular surface anesthesia during ophthalmologic procedures.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Efficacy will be assessed based on following points Grade of anesthesia, Time in onset of anesthesia and Duration of anesthesia
研究概览
简要总结
This study is a Comparative, Randomized, Double Blind, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Lidocaine Hydrochloride Ophthalmic Gel 3.5% Vs Akten (Reference Drug), in patients for ocular surface anesthesia during ophthalmologic procedures. Date of enrollment is 08 Dec 2009. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
Out come will be measured at 0 hr to end of anesthesia in patients for ocular
surface anesthesia during ophthalmologic procedures. The efficacy parameters will primarily focus on Grade of anesthesia, Time in onset of anesthesia and Duration of anesthesia & Secondary focusing onsafety and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 to 60 years.
- •Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
- •Patient undergoing ophthalmologic procedures and requiring ocular anesthesia.
排除标准
- •Patients < 18 & > 60 years
- •History of hypersensitivity to the study drug or similar class of drug.
- •Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications.
- •Pregnant or lactating women.
- •Patients with serum creatinine greater than 2.5 mg/dl.
- •Patients with raised SGPT and total bilirubin greater than 50% above the upper normal limits
- •Significant history or presence of glaucoma, cardiovascular or hematological disease.
- •Any clinical significant illness during the 4 weeks prior to day 1 of this study.
- •Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease.
- •Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study.
- •Use of enzyme-modifying drugs within 30 days prior to day 1 of this study.
- •HIV and Australian Antigen positive subjects.
- •Any condition that, in the opinion of the investigator, does not justify the patients inclusion in the study.
结局指标
主要结局
Efficacy will be assessed based on following points Grade of anesthesia, Time in onset of anesthesia and Duration of anesthesia
时间窗: 0 hr to end of anesthesia
次要结局
- safety and tolerability(0 hr. to day 2nd)
研究者
研究点 (4)
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