A Bioequivalence Study of Tobradex AF

Phase 3

Completed

• Conditions: Cataract
• Interventions: Drug: Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension; Drug: Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)

• Registration Number: NCT00362895
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Study First Submitted: 2006-08-09
• Study First Submitted QC: 2006-08-09
• Study First Posted: 2006-08-15
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-02
• Last Update Posted: 2012-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 995

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tobradex AF	Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension	-
TOBRADEX	Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)	-

Primary Outcome Measures

Name	Time	Method
Concentration of dexamethasone in aqueous humor following a single topical ocular administration

Trial Locations

Locations (1)

Contact Alcon for Trial Location(s); 🇺🇸 Fort Worth, Texas, United States