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).

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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000830

Enrollment

200

Registered

2009-10-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H590- Disorders of the eye following cataract surgery Health Condition 2: null- Ocular surface anesthesia during ophthalmologic procedures

Interventions

Intervention1: Lidocaine Hydrochloride Ophthalmic Gel 3.5%: 2 drops will be applied to the ocular surface in the area of the planned procedure Control Intervention1: Akten: 2 drops will be applied to

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Efficacy will be assessed based on following points Grade of anesthesia, Time in onset of anesthesia and Duration of anesthesia Timepoint: 0 hr to end of anesthesia	—

Secondary

Measure	Time frame
safety and tolerabilityTimepoint: 0 hr. to day 2nd	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd, Advent

shaileshs@ajantapharma.com022-66062112

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026