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Safety and Efficacy Pilot Study of AzaSite (Azithromycin) in Subjects With Blepharitis

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00629590
First received: February 21, 2008
Last updated: September 20, 2011
Last verified: September 2011
History of Changes

February 21, 2008
September 20, 2011
March 2008
July 2008   (final data collection date for primary outcome measure)
Change in clinical signs and symptoms associated with blepharitis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00629590 on ClinicalTrials.gov Archive Site
Standard ocular safety assessments [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Pilot Study of AzaSite (Azithromycin) in Subjects With Blepharitis
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 Two Weeks in Subjects With Posterior Blepharitis

The purpose of this study is to evaluate the safety and efficacy of AzaSite ophthalmic solution, 1% on signs and symptoms of blepharitis.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Blepharitis
Drug: AzaSite®
ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~12 days
Other Name: AzaSite
  • Experimental: 1
    Intervention: Drug: AzaSite®
  • No Intervention: 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Not Provided
July 2008   (final data collection date for primary outcome measure)

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, etc.) within the past year
  • unwilling to discontinue use of contact lenses during the study
  • have glaucoma
  • unable or unwilling to withhold the use of lid 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00629590
041-106, P08649
Not Provided
Inspire Pharmaceuticals, Sponsor
Merck
Not Provided
Study Director: Reza Haque works for Sponsor
Merck
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP