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).
- Conditions
- Health Condition 1: H590- Disorders of the eye following cataract surgeryHealth Condition 2: null- Ocular surface anesthesia during ophthalmologic procedures
- Registration Number
- CTRI/2009/091/000830
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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.
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 <br/ ><br>Timepoint: 0 hr to end of anesthesia
- Secondary Outcome Measures
Name Time Method safety and tolerabilityTimepoint: 0 hr. to day 2nd