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

Phase 3

Completed

Brief Summary: A Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Loteprednol etabonate + Gatifloxacin eye drops Vs.Gatifloxacin + Dexamethasone eye drops in patients with Inflammatory ocular conditions where bacterial ocular infection or a risk of ocular infection exist.The trial will be conducted on 100 patients and study will start on 21 oct 2010.

The primary outcome will be to measured inflammation by slit lamp biomicroscopic & following parameters will be assessed at Day 0, 3rd day, 5th day & 7th day.- Improvement in ocular inflammation and bacterial infection., Red or pink eyes, Eyelids sticking together especially in the morning,Itching,Excess tearing, White-yellow or cream colour thick sticky discharge, Watery discharge,Pain may be present,Virus infections and allergies often affect both eyes,Bleeding or hemorrhage can be seen as rupture of tiny blood vessels,Swelling of conjunctiva,Sensitivity to light,Swelling and redness for as long as 4 to 6 weeks after surgery,Decrease in visual acuity, sometimes caused by cystoid macular edema and secondary outcome will be Global assessment of efficacy and tolerability at 7th day.

Recruitment & Eligibility

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

Patients < 18 & > 65 years.History of hypersensitivity to the study drug or similar class of drug.Pregnant or nursing femalesParticipation 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.

Primary Outcome Measures

Name	Time	Method
Improvement in ocular inflammation and bacterial infection	Day 0, day 3, day 5 & day 7.

Secondary Outcome Measures

Name	Time	Method
Global assessment of efficacy and tolerability	7th day

Locations (3): Aadit Hospital
🇮🇳
Valsad, GUJARAT, India
Shitij Eye Care Centre
🇮🇳
Mumbai, MAHARASHTRA, India
Tulsi Eye Hospital
🇮🇳
Nashik, MAHARASHTRA, India
Aadit Hospital
🇮🇳Valsad, GUJARAT, India
Dr Shilpa Shah
Principal investigator
09924119912
aadithospital@yahoo.com