Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis

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%

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00629941

Enrollment

Registered

2008-03-06

Start date

2008-03-31

Completion date

Unknown

Last updated

2011-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blepharitis

Brief summary

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

Interventions

DRUGAzaSite®

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in clinical signs and symptoms associated with blepharitis	8 weeks

Secondary

Measure	Time frame
Standard ocular safety assessments	4 weeks
Change in tear cytokine and eyelid bacterial load levels	4 Weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026