NCT00629941

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2008

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Last Updated

September 26, 2011

Status Verified

September 1, 2011

Enrollment Period

5 months

First QC Date

February 27, 2008

Last Update Submit

September 20, 2011

Conditions

Blepharitis

Outcome Measures

Primary Outcomes (1)

  • Change in clinical signs and symptoms associated with blepharitis

    8 weeks

Secondary Outcomes (2)

  • Standard ocular safety assessments

    4 weeks

  • Change in tear cytokine and eyelid bacterial load levels

    4 Weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: AzaSite®

Interventions

AzaSite®DRUG

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Maine Eye Care

Lewiston, Maine, 04240, United States

Location

Ophthalmic Research Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Blepharitis

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Reza Haque, MD

    Sponsor GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 27, 2008

First Posted

March 6, 2008

Study Start

March 1, 2008

Primary Completion

August 1, 2008

Last Updated

September 26, 2011

Record last verified: 2011-09

Locations

US(2)