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OpenTrials
Completed

NCT Number: NCT00629941

Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis

The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs & symptoms of blepharitis and tear cytokine and eyelid bacterial load levels

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Key information

Conditions

Blepharitis Eye Diseases Eyelid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Central Maine Eye Care, Lewiston, Maine, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of moderate to severe chronic blepharitis
  • If female of childbearing potential, are non-pregnant and non-lactating

Exclusion criteria

  • Had ocular surface surgery (LASIK, refractive, etc.) within the past year
  • Unwilling to discontinue use of contact lenses during the study
  • Have glaucoma
  • Unable or unwilling to withhold the use of lid scrubs during the study
  • Have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance
  • Currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation

Treatment and study plan

AzaSite®

Drug

Ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~26 days

Primary outcomes

  1. Change in clinical signs and symptoms associated with blepharitis

    Time frame: 8 weeks

Secondary outcomes

  1. Standard ocular safety assessments

    Time frame: 4 weeks

  2. Change in tear cytokine and eyelid bacterial load levels

    Time frame: 4 Weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multi-Center, Open-Label Study Evaluating the Cytokine and Eyelid Margin Bacterial Load Levels of Subjects Diagnosed With Chronic Blepharitis Following Dosing With AzaSite® (Azithromycin Ophthalmic Solution) 1%

Important dates

Study start
2008
Primary completion
2008
First posted
Mar 6, 2008
Registry last updated
Sep 26, 2011

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.

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