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

Blepharitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00892970
• Other study ID #: 044-101
• Secondary ID: P08639
• Status: Completed
• Phase: Phase 2
• First received: May 1, 2009
• Last updated: September 20, 2011
• Start date: April 2009
• Est. completion date: January 2010

Study information

• Verified date: September 2011
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharitis

Intervention

Drug:
• Azithromycin ophthalmic solution, 1%
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
• Placebo
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

Locations

Country	Name	City	State
United States	Sall Medical Research Center	Artesia	California
United States	Eye Clinic of Austin	Austin	Texas
United States	Milton Hom, OD	Azusa	California
United States	Wilmer Eye Institute, Johns Hopkins Hospital	Baltimor	Maryland
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Florida Eye Microsurgical Institute	Boynton Beach	Florida
United States	Mundorf Eye Center	Charlotte	North Carolina
United States	Abrams Eye Center	Cleveland	Ohio
United States	Eye Centers of Florida	Fort Myers	Florida
United States	NorthShore University HealthSystems	Glenview	Illinois
United States	TLC Laser Eye Center	Greensboro	North Carolina
United States	Eye Center - A Medical and Surgical Group	Hamden	Connecticut
United States	Cornerstone Eye Care	High Point	North Carolina
United States	Chicago Cornea Consultants	Hoffman Estates	Illinois
United States	Indiana University School of Medicine, Ophthalmology Dept.	Indianapolis	Indiana
United States	Eye Physicians and Surgeons, LLP	Iowa City	Iowa
United States	Koffler Vision Group	Lexington	Kentucky
United States	Jones Eye Institute	Little Rock	Arkansas
United States	The Jules Stein Eye Institute UCLA Laser Refractive Center	Los Angeles	California
United States	See Clearly Vision Group	McLean	Virginia
United States	Minnesota Eye Consultants	Minneapolis	Minnesota
United States	North Valley Eye Medical Group	Mission Hills	California
United States	McCabe Vision Center	Murfreesboro	Tennessee
United States	David Wirta, MD, Inc.	Newport Beach	California
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	North Bay Eye Associates	Petaluma	California
United States	West Coast Eye Care	San Diego	California
United States	Ophthalmology Associates	St. Louis	Missouri
United States	Ophthalmology Consultants	St. Louis	Missouri
United States	Wolstan Eye Associates	Torrence	California
United States	South Shore Eye Care	Wantagh	New York
United States	Brar-Parekh Eye Associates	West Paterson	New Jersey
United States	Bucci Laser Vision Institute	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eyelid margin erythema		Two weeks	No
Secondary	Signs and symptoms of Blepharitis		One week, two weeks, three weeks, four weeks	No