NCT02734459

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

A Multi Center, Open Label, Randomized, Two- Treatment, Single Dose, Crossover, Bioequivalence Study To Compare The Pharmacokinetics Of Marketed Product TobraDex® (Tobramycin And Dexamethasone Ophthalmic Ointment) To An Experimental Ophthalmic Sterile Ointment Containing Tobramycin 0.3% And Dexamethasone 0.1% W/W In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 756 (actual)
• Sponsor: Semler Research Center Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bilateral Cataract

Interventions

Type	Name	Description
DRUG	cataract surgery	the patient will be dosed with the study drug into the "V" pocket is formed between the eye ball and the lower eyelid during cataract surgery.

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-10-01
• Completion: 2016-03-01
• First posted: 2016-04-12
• Last updated: 2016-04-12