Overview

A Bioequivalence Study to Compare the Pharmacokinetics (PK) Of Marketed Product TobraDex® To An Experimental Ophthalmic Sterile Ointment Containing Tobramycin And Dexamethasone In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery

Status:
Completed

Trial end date:
2016-03-01

Target enrollment:

Participant gender:

Summary

Each patient will be randomized to receive one dose of the test article in one eye and one dose of the reference formulations in the contralateral eye. One eye will be selected as the initial eye for cataract surgery and aqueous humor collection and hence will be dosed and operated on first. Followed by the second eye which will be dosed no early than a week followed by aqueous humor collection as per specified time points and no later than 35 days following the first eye again prior to the cataract surgery.

Phase:

Phase 3

Details

Lead Sponsor:

Semler Research Center Pvt. Ltd.

Collaborators:

Genzum Life Sciences
GenZum Life Sciences LLC

Treatments:

BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Tobramycin