A Bioequivalence Study of Tobradex AF

Alcon

Status and phase: Completed; Phase 3

Conditions: Cataract

Treatments: Drug: Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX); Drug: Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT00362895

C-05-23

Details and patient eligibility

About

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.

Enrollment: 995 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 or older
• Other protocol-defined inclusion criteria may apply

Exclusion criteria

• Under 18
• Other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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995 participants in 2 patient groups

Tobradex AF

Experimental group

Treatment:

Drug: Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension

TOBRADEX

Active Comparator group

Treatment:

Drug: Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)