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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

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Blepharitis

Intervention: Tobradex ST (Drug); Azasite (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Alcon Research

Summary

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.

Clinical Details

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Global sign and symptom score for blepharitis

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Ora, Andover, Massachusetts 01810, United States
Additional Information

Starting date: April 2010
Last updated: June 7, 2012

Page last updated: August 23, 2015

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