A Bioequivalence Study of Tobradex AF

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Contact Alcon for Trial Location(s)

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 or older
Other protocol-defined inclusion criteria may apply

Exclusion criteria

Under 18
Other protocol-defined exclusion criteria may apply

Treatment and study plan

Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension

Drug

One drop in the study eye, single dose

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

Drug

One drop in the study eye, single dose

Other names: TOBRADEX®

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: Aug 15, 2006
Registry last updated: Mar 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed