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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Blepharitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Tobradex ST

tobramycin 0.3%, dexamethasone 0.05%

Group Type EXPERIMENTAL

Tobradex ST

Intervention Type DRUG

tobramycin / dexamethasone ophthalmic suspension 0.3%/0.05% 1 drop 4 times daily for 14 days

Azasite

azithromycin 1%

Group Type ACTIVE_COMPARATOR

Azasite

Intervention Type DRUG

azithromycin 1% 1 drop twice daily for 2 days, then once daily for 12 days

Interventions

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Tobradex ST

tobramycin / dexamethasone ophthalmic suspension 0.3%/0.05% 1 drop 4 times daily for 14 days

Intervention Type DRUG

Azasite

azithromycin 1% 1 drop twice daily for 2 days, then once daily for 12 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No