A Study to Evaluate the Clinical Efficacy and Safety of Tobradex® ST Compared to Azasite® in the Treatment of Subjects With Moderate to Severe Chronic Blepharitis

June 7, 2012 updated by: Alcon Research
The purpose of this study is to evaluate the clinical efficacy and safety of Tobradex ST compared to AzaSite in the treatment of moderate to severe chronic blepharitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • Ora

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have diagnosis of moderate to severe chronic blepharitis defined by a minimum score of at least "1" for one of the lid signs, one of the conjunctival signs, and one of the symptoms in at least one eye
  • Have a minimum global score (the total signs and symptoms score) of 5 in the same eye qualifying.

Exclusion Criteria:

  • Have known sensitivity or poor tolerance to the test article (tobramycin, dexamethasone, azithromycin) or its components or any therapy associated with the trial
  • Have a history of ocular surgical intervention within six (6) weeks prior to Visit 1 or during the study
  • Have any ocular infections (bacterial, viral or fungal) - active ocular inflammation (i.e. follicular conjunctivitis, iritis) or preauricular lymphadenopathy, other than blepharitis
  • Have worn contact lenses in the 72 hours prior to visit 1 and for the duration of the study
  • Are currently taking any medication known to cause ocular drying that has not been on a stable dose for at least 30 days
  • Have used any topical ocular or systemic antibiotics within 7 days of enrollment. Stable (greater than 1 month prior to enrollment) use of topical antibiotics on the face (except around the eyes) for dermatologic conditions is allowed. Dose must continue unchanged for duration of study
  • Have used any topical ocular - aerosolized/nebulized - or systemic corticosteroid agents within 14 days of enrollment. Stable (greater than 1 month prior to enrollment) use of inhaled (using mouthpiece) and nasal corticosteroids and topical dermal steroids (except around the eyelids) are allowed. Dose must continue unchanged for the duration of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tobradex ST
tobramycin 0.3%, dexamethasone 0.05%
Drug: Tobradex ST
tobramycin / dexamethasone ophthalmic suspension 0.3%/0.05% 1 drop 4 times daily for 14 days
ACTIVE_COMPARATOR: Azasite
azithromycin 1%
Drug: Azasite
azithromycin 1% 1 drop twice daily for 2 days, then once daily for 12 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Global sign and symptom score for blepharitis
Time Frame: Day 15
Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

April 9, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (ESTIMATE)

April 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 11, 2012

Last Update Submitted That Met QC Criteria

June 7, 2012

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMA-09-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Blepharitis

Clinical Trials on Tobradex ST

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe