Safety and Efficacy Pilot Study of AzaSite® for Four Weeks in Subjects With Blepharitis

Blepharitis Clinical Trial

Official title:

A Single-Center, Open-Label, Randomized Pilot Study of the Safety and Efficacy of AzaSite® Ophthalmic Solution, 1% in Combination With Mechanical Therapy Versus Mechanical Therapy Alone for Four Weeks in Subjects With Posterior Blepharitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656539
• Other study ID #: 041-107
• Secondary ID: P08647
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2008
• Last updated: September 20, 2011
• Start date: April 2008

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 purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs and symptoms of blepharitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of moderate to severe chronic posterior blepharitis

• If female of childbearing potential, are non-pregnant and non-lactating

Exclusion Criteria:

• had ocular surface surgery (LASIK, refractive, pterygium) within the past year

• unwilling to discontinue use of contact lenses during the study

• have glaucoma

• unable or unwilling to withhold the use of eyelid scrubs during the study

• have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance

• currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharitis

Intervention

Drug:
• AzaSite®
Ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~26 days

Locations

Country	Name	City	State
United States	Ophthalmic Consultants of Long Island	Lynbrook	New York

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	Change in clinical signs and symptoms associated with blepharitis		4 weeks	No
Secondary	Standard ocular safety assessments		4 weeks	No