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Safety and Efficacy Pilot Study of AzaSite® for Four Weeks 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 posterior blepharitis
  • If female of childbearing potential, are non-pregnant and non-lactating

Exclusion Criteria:

  • had ocular surface surgery (LASIK, refractive, pterygium) within the past year
  • unwilling to discontinue use of contact lenses during the study
  • have glaucoma
  • unable or unwilling to withhold the use of eyelid 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

  • Ophthalmic Consultants of Long Island

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

AzaSite®

Outcomes

Primary Outcome Measures

Change in clinical signs and symptoms associated with blepharitis

Secondary Outcome Measures

Standard ocular safety assessments

Full Information

First Posted
April 7, 2008
Last Updated
September 20, 2011
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00656539
Brief Title
Safety and Efficacy Pilot Study of AzaSite® for Four Weeks in Subjects With Blepharitis
Official Title
A Single-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 for Four Weeks in Subjects With Posterior Blepharitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

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
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
AzaSite®
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 posterior blepharitis If female of childbearing potential, are non-pregnant and non-lactating Exclusion Criteria: had ocular surface surgery (LASIK, refractive, pterygium) within the past year unwilling to discontinue use of contact lenses during the study have glaucoma unable or unwilling to withhold the use of eyelid 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
Medical Monitor
Official's Role
Study Director
Facility Information:
Facility Name
Ophthalmic Consultants of Long Island
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States

12. IPD Sharing Statement

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Safety and Efficacy Pilot Study of AzaSite® for Four Weeks in Subjects With Blepharitis

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