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.

Ajanta Pharma Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Age 18 to 60 years.
•2. Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
•3. Patient undergoing ophthalmologic procedures and requiring ocular anesthesia.

•1. Patients < 18 & > 60 years
•2. History of hypersensitivity to the study drug or similar class of drug.
•3. 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.
•4. Pregnant or lactating women.
•5. Patients with serum creatinine greater than 2.5 mg/dl.
•6. Patients with raised SGPT and total bilirubin greater than 50% above the upper normal limits
•7. Significant history or presence of glaucoma, cardiovascular or hematological disease.
•8. Any clinical significant illness during the 4 weeks prior to day 1 of this study.
•9. Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease.
•10. Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study.
•11. Use of enzyme-modifying drugs within 30 days prior to day 1 of this study.
•12. HIV and Australian Antigen positive subjects.
•13. Any condition that, in the opinion of the investigator, does not justify the patients inclusion in the study.

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