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

Phase 2
Completed
Conditions
Blepharitis
Interventions
Registration Number
NCT00892970
Lead Sponsor
Merck Sharp & Dohme LLC
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
313
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
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1Azithromycin ophthalmic solution, 1%-
2Placebo-
Primary Outcome Measures
NameTimeMethod
Eyelid margin erythemaTwo weeks
Secondary Outcome Measures
NameTimeMethod
Signs and symptoms of BlepharitisOne week, two weeks, three weeks, four weeks

Trial Locations

Locations (33)

Ophthalmology Associates

🇺🇸

St. Louis, Missouri, United States

Wilmer Eye Institute, Johns Hopkins Hospital

🇺🇸

Baltimor, Maryland, United States

Milton Hom, OD

🇺🇸

Azusa, California, United States

The Jules Stein Eye Institute UCLA Laser Refractive Center

🇺🇸

Los Angeles, California, United States

David Wirta, MD, Inc.

🇺🇸

Newport Beach, California, United States

NorthShore University HealthSystems

🇺🇸

Glenview, Illinois, United States

Indiana University School of Medicine, Ophthalmology Dept.

🇺🇸

Indianapolis, Indiana, United States

Wolstan Eye Associates

🇺🇸

Torrence, California, United States

TLC Laser Eye Center

🇺🇸

Greensboro, North Carolina, United States

Eye Physicians and Surgeons, LLP

🇺🇸

Iowa City, Iowa, United States

North Bay Eye Associates

🇺🇸

Petaluma, California, United States

See Clearly Vision Group

🇺🇸

McLean, Virginia, United States

Ophthalmology Consultants

🇺🇸

St. Louis, Missouri, United States

Bucci Laser Vision Institute

🇺🇸

Wilkes-Barre, Pennsylvania, United States

West Coast Eye Care

🇺🇸

San Diego, California, United States

Koffler Vision Group

🇺🇸

Lexington, Kentucky, United States

North Valley Eye Medical Group

🇺🇸

Mission Hills, California, United States

Minnesota Eye Consultants

🇺🇸

Minneapolis, Minnesota, United States

Eye Clinic of Austin

🇺🇸

Austin, Texas, United States

Virginia Eye Consultants

🇺🇸

Norfolk, Virginia, United States

Brar-Parekh Eye Associates

🇺🇸

West Paterson, New Jersey, United States

Eye Centers of Florida

🇺🇸

Fort Myers, Florida, United States

Ophthalmic Consultants of Boston

🇺🇸

Boston, Massachusetts, United States

South Shore Eye Care

🇺🇸

Wantagh, New York, United States

Mundorf Eye Center

🇺🇸

Charlotte, North Carolina, United States

Jones Eye Institute

🇺🇸

Little Rock, Arkansas, United States

Eye Center - A Medical and Surgical Group

🇺🇸

Hamden, Connecticut, United States

Abrams Eye Center

🇺🇸

Cleveland, Ohio, United States

Florida Eye Microsurgical Institute

🇺🇸

Boynton Beach, Florida, United States

Sall Medical Research Center

🇺🇸

Artesia, California, United States

Chicago Cornea Consultants

🇺🇸

Hoffman Estates, Illinois, United States

Cornerstone Eye Care

🇺🇸

High Point, North Carolina, United States

McCabe Vision Center

🇺🇸

Murfreesboro, Tennessee, United States

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