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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00894530
Other study ID # P08638
Secondary ID 044-102
Status Completed
Phase Phase 2
First received May 5, 2009
Last updated October 29, 2013
Start date May 2009
Est. completion date December 2009

Study information

Verified date October 2013
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 four-week treatment period.


Recruitment information / eligibility

Status Completed
Enrollment 314
Est. completion date December 2009
Est. primary completion date December 2009
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


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 26 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 26 days

Locations

Country Name City State
United States Sall Research Medical Center Artesia California
United States Sall Research Medical Center, Inc. Artesia California
United States Eastern Maine Medical Center Bangor Maine
United States Wohl Eye Center Bloomingdale Illinois
United States Hernando Eye Institute Brooksville Florida
United States Columbus Ophthalmology Associates Columbus Ohio
United States Ohio State University - College of Optometry Columbus Ohio
United States Park Ophthalmology Durham North Carolina
United States McDonald Eye Associates Fayetteville Arkansas
United States United Medical Research Company Inglewood California
United States Taustine Eye Center Louisville Kentucky
United States Ophthalmic Consultants of Long Island Lynbrook New York
United States Total Eye Care, PA Memphis Tennessee
United States Center for Excellence in Eye Care Miami Florida
United States North Valley Eye Medical Group Mission Hills California
United States Coastal Vision Medical Group Newport Beach California
United States Philadelphia Eye Associates Philadelphia Pennsylvania
United States Eye Clinics of South Texas San Antonio Texas
United States West Coast Eye Care San Diego California
United States Schwartz Laser Eye Center Scottsdale Arizona
United States David M. Ringel, DO, PA Sewell New Jersey
United States Ophthalmology Associates St Louis Missouri
United States Thomas John Vision Institute Tinley Park Illinois
United States Comprehensive Eye Care Ltd Washington Missouri
United States Brar-Parekh Eye Associates West Paterson New Jersey
United States Grene Vision Group Wichita Kansas

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 Four weeks No
Secondary Signs and symptoms of Blepharitis One week, two weeks, three weeks, four weeks, six weeks, eight weeks No
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