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

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

  • Jones Eye Institute
  • Sall Medical Research Center
  • Milton Hom, OD
  • The Jules Stein Eye Institute UCLA Laser Refractive Center
  • North Valley Eye Medical Group
  • David Wirta, MD, Inc.
  • North Bay Eye Associates
  • West Coast Eye Care
  • Wolstan Eye Associates
  • Eye Center - A Medical and Surgical Group
  • Florida Eye Microsurgical Institute
  • Eye Centers of Florida
  • NorthShore University HealthSystems
  • Chicago Cornea Consultants
  • Indiana University School of Medicine, Ophthalmology Dept.
  • Eye Physicians and Surgeons, LLP
  • Koffler Vision Group
  • Wilmer Eye Institute, Johns Hopkins Hospital
  • Ophthalmic Consultants of Boston
  • Minnesota Eye Consultants
  • Ophthalmology Associates
  • Ophthalmology Consultants
  • Brar-Parekh Eye Associates
  • South Shore Eye Care
  • Mundorf Eye Center
  • TLC Laser Eye Center
  • Cornerstone Eye Care
  • Abrams Eye Center
  • Bucci Laser Vision Institute
  • McCabe Vision Center
  • Eye Clinic of Austin
  • See Clearly Vision Group
  • Virginia Eye Consultants

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 1, 2009
Last Updated
September 20, 2011
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00892970
Brief Title
The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Two-Week Treatment Period
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

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 two-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
313 (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 12 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 12 days
Primary Outcome Measure Information:
Title
Eyelid margin erythema
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Signs and symptoms of Blepharitis
Time Frame
One week, two weeks, three weeks, four 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
Jones Eye Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Sall Medical Research Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Milton Hom, OD
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
The Jules Stein Eye Institute UCLA Laser Refractive Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
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
David Wirta, MD, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
North Bay Eye Associates
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
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
Wolstan Eye Associates
City
Torrence
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Eye Center - A Medical and Surgical Group
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Florida Eye Microsurgical Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Eye Centers of Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
NorthShore University HealthSystems
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60025
Country
United States
Facility Name
Chicago Cornea Consultants
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Indiana University School of Medicine, Ophthalmology Dept.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Eye Physicians and Surgeons, LLP
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52245
Country
United States
Facility Name
Koffler Vision Group
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Wilmer Eye Institute, Johns Hopkins Hospital
City
Baltimor
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Minnesota Eye Consultants
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Ophthalmology Associates
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Ophthalmology Consultants
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63131
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
South Shore Eye Care
City
Wantagh
State/Province
New York
ZIP/Postal Code
11793
Country
United States
Facility Name
Mundorf Eye Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
TLC Laser Eye Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
Cornerstone Eye Care
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Abrams Eye Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Bucci Laser Vision Institute
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18702
Country
United States
Facility Name
McCabe Vision Center
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37129
Country
United States
Facility Name
Eye Clinic of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
See Clearly Vision Group
City
McLean
State/Province
Virginia
ZIP/Postal Code
22101
Country
United States
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
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 Two-Week Treatment Period

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