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OpenTrials
Completed

NCT Number: NCT01102244

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ora

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Tobradex ST

Drug

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

AzaSite

Drug

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

Primary outcomes

  1. Global sign and symptom score for blepharitis

    Time frame: Day 15

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
First posted
Apr 13, 2010
Registry last updated
Jun 11, 2012

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.

Published trials that share one or more normalized conditions with this study.