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

NCT ID: NCT00576251

Last Updated: 2010-03-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ocular Inflammation Associated With Blepharaconjunctivitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tobramycin 0.3%/Dexamethasone 0.05%

Tobramycin 0.3%/Dexamethasone 0.05% 1 drop 4 times daily in both eyes

Group Type EXPERIMENTAL

Tobramycin 0.3%/Dexamethasone 0.05%

Intervention Type DRUG

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

TOBRADEX

TOBRADEX 1 drop 4 times daily in both eyes

Group Type ACTIVE_COMPARATOR

TOBRADEX

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tobramycin 0.3%/Dexamethasone 0.05%

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

Intervention Type DRUG

TOBRADEX

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Ocular inflammation associated with blepharaconjunctivitis

Exclusion Criteria

* ocular allergy
* ocular disorders that would preclude safe administration of test article
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alcon Research

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Brubaker, BSN MPH

Role: STUDY_DIRECTOR

Alcon Research

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Houston

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C-07-19

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.