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OpenTrials
Completed

NCT Number: NCT00576251

TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension

The purpose of this study is to describe the differences in efficacy between TOBRADEX Ophthalmic Suspension and Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension in the treatment of ocular inflammation and infection associated with blepharaconjunctivitis

Completed

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Key information

Conditions

Ocular Inflammation Associated With Blepharaconjunctivitis

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Houston

Houston, Texas, 77090, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ocular inflammation associated with blepharaconjunctivitis

Exclusion criteria

  • ocular allergy
  • ocular disorders that would preclude safe administration of test article

Treatment and study plan

Tobramycin 0.3%/Dexamethasone 0.05%

Drug

Tobramycin 0.3%/Dexamethasone 0.05% 1 drop in both eyes 4 times daily for at least 3 days

TOBRADEX

Drug

TOBRADEX 1 drop in both eyes 4 times daily for at least 3 days

Primary outcomes

  1. Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4)

    Time frame: Day 4 - Test Of Cure (TOC) compared to Day 0

    Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 19, 2007
Registry last updated
Mar 2, 2010

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.