Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00629980
Recruitment Status : Completed
First Posted : March 6, 2008
Last Update Posted : September 26, 2011
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE February 27, 2008
First Posted Date  ICMJE March 6, 2008
Last Update Posted Date September 26, 2011
Study Start Date  ICMJE February 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2008)
change in clinical signs and symptoms associated with blepharitis [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2008)
standard ocular safety assessments [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Pilot Study of AzaSite® (Azithromycin) in Subjects With Blepharitis
Official Title  ICMJE A Multi-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 in Subjects With Blepharitis
Brief Summary The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs and symptoms of blepharitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Blepharitis
Intervention  ICMJE Drug: AzaSite®
ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~26 days
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: AzaSite®
  • No Intervention: 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 5, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diagnosis of moderate to severe chronic 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 the 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00629980
Other Study ID Numbers  ICMJE 041-105
P08651
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mike Schiewe, Inspire Pharmaceuticals, Inc
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Reza Haque, MD Sponsor GmbH
PRS Account Merck Sharp & Dohme Corp.
Verification Date September 2011

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