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Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis

Primary Purpose

Blepharitis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

AzaSite®

About this trial

This is an interventional treatment trial for Blepharitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Central Maine Eye Care
Ophthalmic Research Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change in clinical signs and symptoms associated with blepharitis

Secondary Outcome Measures

Standard ocular safety assessments

Change in tear cytokine and eyelid bacterial load levels

Full Information

NCT ID

NCT00629941

First Posted

February 27, 2008

Last Updated

September 20, 2011

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00629941

Brief Title

Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis

Official 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%

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Blepharitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

AzaSite®

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in clinical signs and symptoms associated with blepharitis

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Standard ocular safety assessments

Time Frame

4 weeks

Title

Change in tear cytokine and eyelid bacterial load levels

Time Frame

4 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Reza Haque, MD

Organizational Affiliation

Sponsor GmbH

Official's Role

Study Director

Facility Information:

Facility Name

Central Maine Eye Care

City

Lewiston

State/Province

Maine

ZIP/Postal Code

04240

Country

United States

Facility Name

Ophthalmic Research Associates

City

Andover

State/Province

Massachusetts

ZIP/Postal Code

01810

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis

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