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Safety and Efficacy Pilot Study of AzaSite® (Azithromycin) in Subjects With Blepharitis

Primary Purpose

Blepharitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AzaSite®
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

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 the 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

  • Sall Research Medical Center
  • North Valley Eye Medical Group
  • Center for Excellence in Eye Care
  • Kentuckiana Institute for Eye Research
  • Tauber Eye Center
  • Silverstein Eye Centers
  • South Shore Eye Care, LLP
  • Toyos Clinic
  • Corona Research Consultants, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

change in clinical signs and symptoms associated with blepharitis

Secondary Outcome Measures

standard ocular safety assessments

Full Information

First Posted
February 27, 2008
Last Updated
September 20, 2011
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00629980
Brief Title
Safety and Efficacy Pilot Study of AzaSite® (Azithromycin) in Subjects With Blepharitis
Official Title
A Multi-Center, Open-Label, Randomized Pilot Study of the Safety and Efficacy of AzaSite® Ophthalmic Solution, 1% in Combination With Mechanical Therapy Versus Mechanical Therapy Alone in Subjects With Blepharitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
September 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 and symptoms of blepharitis.

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
No Intervention
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
4 weeks
Secondary Outcome Measure Information:
Title
standard ocular safety assessments
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 the 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
Sall Research Medical Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
North Valley Eye Medical Group
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Center for Excellence in Eye Care
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Kentuckiana Institute for Eye Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Tauber Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Silverstein Eye Centers
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
South Shore Eye Care, LLP
City
Wantagh
State/Province
New York
ZIP/Postal Code
11793
Country
United States
Facility Name
Toyos Clinic
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
Corona Research Consultants, Inc.
City
El Paso
State/Province
Texas
ZIP/Postal Code
79904
Country
United States

12. IPD Sharing Statement

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Safety and Efficacy Pilot Study of AzaSite® (Azithromycin) in Subjects With Blepharitis

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