A clinical Trial in patients for ocular surface anesthesia during ophthalmologic procedures. Clinical trial is to study efficacy, safety and tolerability of Lidocaine Hydrochloride Ophthalmic Gel 3.5% in comparison to Akten (reference product).

Phase 3

Completed

• Conditions: Disorders of the eye following cataract surgery, Ocular surface anesthesia during ophthalmologic procedures,

• Registration Number: CTRI/2009/091/000830
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-12
• Last Update Posted: 2018-11-23

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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.

Exclusion Criteria

• Patients < 18 & > 60 years2.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy will be assessed based on following points Grade of anesthesia, Time in onset of anesthesia and Duration of anesthesia	0 hr to end of anesthesia

Secondary Outcome Measures

Name	Time	Method
safety and tolerability	0 hr. to day 2nd

Trial Locations

Locations (4)

Dr. Sharad Mistry's Clinic; 🇮🇳 Thane, MAHARASHTRA, India

OM Netralaya; 🇮🇳 Pune, MAHARASHTRA, India

Wadgaonkar Eye Hospital; 🇮🇳 Aurangabad, BIHAR, India

Wockhardt Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Dr. Sharad Mistry's Clinic

🇮🇳Thane, MAHARASHTRA, India

Dr. Sharad Mistry

Principal investigator

09821711054

esmile1614@yahoo.co.in