Clinical trial is to study efficacy, safety and tolerability of Loteprednol etabonate + Gatifloxacin eye drops in comparison to Gatifloxacin + Dexamethasone eye drops (reference product).
- 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
- Registration Number
- CTRI/2010/091/001454
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method