search
Back to results

The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638)

Primary Purpose

Blepharitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Azithromycin ophthalmic solution, 1%
Placebo
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:

  • Have best corrected visual acuity in both eyes of at least +0.7 or better
  • If female, are non-pregnant or non-lactating
  • Have a current diagnosis of blepharitis in one or both eyes

Exclusion Criteria:

  • Have lid structural abnormalities
  • Have suspected ocular fungal or viral infection
  • Have practiced warm compress therapy within 14 days prior to Visit 2
  • Unable to withhold the use of contact lenses during the treatment or follow-up periods
  • Unable to withhold the use of ocular cosmetic products within 24 hours prior to study visits
  • Have had penetrating intraocular surgery within 90 days prior to Visit 2
  • Have had ocular surface surgery within the past year prior to Visit 2
  • Have a serious medical condition which could confound study assessments

Sites / Locations

  • Schwartz Laser Eye Center
  • McDonald Eye Associates
  • Sall Research Medical Center, Inc.
  • Sall Research Medical Center
  • United Medical Research Company
  • North Valley Eye Medical Group
  • Coastal Vision Medical Group
  • West Coast Eye Care
  • Hernando Eye Institute
  • Center for Excellence in Eye Care
  • Wohl Eye Center
  • Thomas John Vision Institute
  • Grene Vision Group
  • Taustine Eye Center
  • Eastern Maine Medical Center
  • Ophthalmology Associates
  • Comprehensive Eye Care Ltd
  • David M. Ringel, DO, PA
  • Brar-Parekh Eye Associates
  • Ophthalmic Consultants of Long Island
  • Park Ophthalmology
  • Ohio State University - College of Optometry
  • Columbus Ophthalmology Associates
  • Philadelphia Eye Associates
  • Total Eye Care, PA
  • Eye Clinics of South Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Eyelid margin erythema

Secondary Outcome Measures

Signs and symptoms of Blepharitis

Full Information

First Posted
May 5, 2009
Last Updated
October 29, 2013
Sponsor
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT00894530
Brief Title
The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief Summary
The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus placebo over a four-week treatment period.

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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
314 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Azithromycin ophthalmic solution, 1%
Intervention Description
One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 days
Primary Outcome Measure Information:
Title
Eyelid margin erythema
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Signs and symptoms of Blepharitis
Time Frame
One week, two weeks, three weeks, four weeks, six weeks, eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have best corrected visual acuity in both eyes of at least +0.7 or better If female, are non-pregnant or non-lactating Have a current diagnosis of blepharitis in one or both eyes Exclusion Criteria: Have lid structural abnormalities Have suspected ocular fungal or viral infection Have practiced warm compress therapy within 14 days prior to Visit 2 Unable to withhold the use of contact lenses during the treatment or follow-up periods Unable to withhold the use of ocular cosmetic products within 24 hours prior to study visits Have had penetrating intraocular surgery within 90 days prior to Visit 2 Have had ocular surface surgery within the past year prior to Visit 2 Have a serious medical condition which could confound study assessments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Haque, MD,PhD
Organizational Affiliation
Medical Monitor, Inspire
Official's Role
Study Chair
Facility Information:
Facility Name
Schwartz Laser Eye Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
McDonald Eye Associates
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Sall Research Medical Center, Inc.
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Sall Research Medical Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
United Medical Research Company
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
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
Coastal Vision Medical Group
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
West Coast Eye Care
City
San Diego
State/Province
California
ZIP/Postal Code
92115-1754
Country
United States
Facility Name
Hernando Eye Institute
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
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
Wohl Eye Center
City
Bloomingdale
State/Province
Illinois
ZIP/Postal Code
60108
Country
United States
Facility Name
Thomas John Vision Institute
City
Tinley Park
State/Province
Illinois
ZIP/Postal Code
60477
Country
United States
Facility Name
Grene Vision Group
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Taustine Eye Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Ophthalmology Associates
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Comprehensive Eye Care Ltd
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
David M. Ringel, DO, PA
City
Sewell
State/Province
New Jersey
ZIP/Postal Code
08080
Country
United States
Facility Name
Brar-Parekh Eye Associates
City
West Paterson
State/Province
New Jersey
ZIP/Postal Code
07424
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Facility Name
Park Ophthalmology
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Ohio State University - College of Optometry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Columbus Ophthalmology Associates
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Philadelphia Eye Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
Facility Name
Total Eye Care, PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Eye Clinics of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638)

We'll reach out to this number within 24 hrs