Clinical trial is to study efficacy, safety and tolerability of Loteprednol etabonate + Gatifloxacin eye drops in comparison to Gatifloxacin + Dexamethasone eye drops (reference product).

A Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Loteprednol etabonate 0.5 % + Gatifloxacin 0.3 % eye drops Vs. Gatifloxacin 0.3 % + Dexamethasone 0.1 % eye drops in patients with Inflammatory ocular conditions where bacterial ocular infection or a risk of ocular infection exist.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001454

Enrollment

100

Registered

2010-10-11

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: null- In patients with Inflammatory ocular conditions where bacterial ocular infection or a risk of ocular infection exist. Health Condition 2: H571- Ocular pain

Interventions

Intervention1: Loteprednol etabonate + gatifloxacin eye drops: 1 drop 4 times per day for 7 days Control Intervention1: Gatifloxacin + Dexamethasone eye drops: 1 drop 4 times per day for 7 days

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects who have the ability to understand and sign an informed consent form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization. 2.Subjects who are candidate for routine, uncomplicated cataractsurgery. 3.Subjects who are not of childbearing potential. Subjects must be willing and able to comply with all treatment and follow- up procedures.

Exclusion criteria

Exclusion criteria: Patients < 18 & > 65 years. History of hypersensitivity to the study drug or similar class of drug. Pregnant or nursing females Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study. Subjects who have a history or presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or compound the result of the study. Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up. Subjects with elevated intraocular pressure (>/= 21 mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye. Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.

Design outcomes

Primary

Measure	Time frame
Improvement in ocular inflammation and bacterial infectionTimepoint: Day 0, day 3, day 5 & day 7.;Improvement in ocular inflammation and bacterial infectionTimepoint: Day 0, day 3, day 5 & day 7.	—

Secondary

Measure	Time frame
Global assessment of efficacy and tolerabilityTimepoint: 7th day	—

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