Clinical trial NCT00892970: The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Two-Week Treatment Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Blepharitis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-05-05
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Eyelid margin erythema
timeFrame: Two weeks
Secondary outcomes:
measure: Signs and symptoms of Blepharitis
timeFrame: One week, two weeks, three weeks, four weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Jones Eye Institute
state: Arkansas
city: Artesia
country: United States
facility: Sall Medical Research Center
state: California
city: Azusa
country: United States
facility: Milton Hom, OD
state: California
city: Los Angeles
country: United States
facility: The Jules Stein Eye Institute UCLA Laser Refractive Center
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group
state: California
city: Newport Beach
country: United States
facility: David Wirta, MD, Inc.
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: San Diego
country: United States
facility: West Coast Eye Care
state: California
city: Torrence
country: United States
facility: Wolstan Eye Associates
state: California
city: Hamden
country: United States
facility: Eye Center - A Medical and Surgical Group
state: Connecticut
city: Boynton Beach
country: United States
facility: Florida Eye Microsurgical Institute
state: Florida
city: Fort Myers
country: United States
facility: Eye Centers of Florida
state: Florida
city: Glenview
country: United States
facility: NorthShore University HealthSystems
state: Illinois
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine, Ophthalmology Dept.
state: Indiana
city: Iowa City
country: United States
facility: Eye Physicians and Surgeons, LLP
state: Iowa
city: Lexington
country: United States
facility: Koffler Vision Group
state: Kentucky
city: Baltimor
country: United States
facility: Wilmer Eye Institute, Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Minneapolis
country: United States
facility: Minnesota Eye Consultants
state: Minnesota
city: St. Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: St. Louis
country: United States
facility: Ophthalmology Consultants
state: Missouri
city: West Paterson
country: United States
facility: Brar-Parekh Eye Associates
state: New Jersey
city: Wantagh
country: United States
facility: South Shore Eye Care
state: New York
city: Charlotte
country: United States
facility: Mundorf Eye Center
state: North Carolina
city: Greensboro
country: United States
facility: TLC Laser Eye Center
state: North Carolina
city: High Point
country: United States
facility: Cornerstone Eye Care
state: North Carolina
city: Cleveland
country: United States
facility: Abrams Eye Center
state: Ohio
city: Wilkes-Barre
country: United States
facility: Bucci Laser Vision Institute
state: Pennsylvania
city: Murfreesboro
country: United States
facility: McCabe Vision Center
state: Tennessee
city: Austin
country: United States
facility: Eye Clinic of Austin
state: Texas
city: McLean
country: United States
facility: See Clearly Vision Group
state: Virginia
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
affiliation: Medical Monitor, Inspire
name: Reza Haque, MD, PhD
role: STUDY_CHAIR
References: