A Double-Masked, Parallel-Group, Randomized, Single-Dose Bioequivalence Study of Tobradex AF Suspension and TOBRADEX Ophthalmic Suspension

NCT00362895 Phase 3 COMPLETED

The purpose of the study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.

Details

Lead sponsor	Alcon Research
Phase	Phase 3
Status	COMPLETED
Enrolment	995
Start date	2006-04
Completion	2006-08

Conditions

• Cataract

Interventions

• Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension
• Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)

Primary outcomes

• Concentration of dexamethasone in aqueous humor following a single topical ocular administration

Countries

United States