Back to resultsStudy of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers
Primary Purpose
Bacterial Infections, Eye Infections
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Azithromycin
Moxifloxacin
Sponsored by
About this trial
This is an interventional supportive care trial for Bacterial Infections
Eligibility Criteria
Inclusion Criteria:
- Have best corrected visual acuity of 0.60 logMAR or better in each eye as measured using Early Treatment of Diabetic Retinopathy Study chart
Exclusion Criteria:
- Have a known allergy and/or sensitivity to the test article(s) or its components or any therapies associated with the trial
- Have active signs or symptoms of any clinically significant ocular disorder (other than refractive disorders)
- Have a known bleeding disorder or history of bleeding complications after surgical or dental procedures
- Take aspirin, or take any other blood thinners or anti-coagulants (e.g. warfarin) including prescription, over the counter, or homeopathic therapies
- Have undergone any ocular surgical intervention within 3 months prior to Visit 1 or anticipate having ocular surgery during the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Azithromycin-30 minutes Post dose
Azithromycin-2 hours post dose
Azithromycin-12 hours post dose
Azithromycin-24 hours post dose
Moxifloxacin-30 minutes post dose
Moxifloxacin-2 hours post dose
Moxifloxacin-12 hours post dose
Moxafloxacin-24 hours post dose
Arm Description
Outcomes
Primary Outcome Measures
Assessment of Pharmacokinetic Parameters
Assessment of Pharmacokinetic Parameters
Conjunctiva Concentration of Azithromycin and Moxifloxacin
Secondary Outcome Measures
Full Information
NCT ID
NCT00564447
First Posted
November 20, 2007
Last Updated
September 20, 2011
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00564447
Brief Title
Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers
Official Title
A Single-Center, Open-Label, Randomized Study of the Pharmacokinetics of AzaSite Ophthalmic Solution Versus Vigamox in the Conjunctiva of Healthy Volunteers Following a Single Ocular Administration
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the drug concentrations of AzaSite™ compared to Vigamox at various time points in conjunctiva tissue of healthy volunteers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections, Eye Infections
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Azithromycin-30 minutes Post dose
Arm Type
Experimental
Arm Title
Azithromycin-2 hours post dose
Arm Type
Experimental
Arm Title
Azithromycin-12 hours post dose
Arm Type
Experimental
Arm Title
Azithromycin-24 hours post dose
Arm Type
Experimental
Arm Title
Moxifloxacin-30 minutes post dose
Arm Type
Experimental
Arm Title
Moxifloxacin-2 hours post dose
Arm Type
Experimental
Arm Title
Moxifloxacin-12 hours post dose
Arm Type
Experimental
Arm Title
Moxafloxacin-24 hours post dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
AzaSite
Intervention Description
azithromycin topical solution 1% given as a single drop in a single eye
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Other Intervention Name(s)
Vigamox
Intervention Description
Moxifloxacin topical solution given as a single drop in a single eye
Primary Outcome Measure Information:
Title
Assessment of Pharmacokinetic Parameters
Time Frame
Up to 24 hours
Title
Assessment of Pharmacokinetic Parameters
Description
Conjunctiva Concentration of Azithromycin and Moxifloxacin
Time Frame
Over 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Have best corrected visual acuity of 0.60 logMAR or better in each eye as measured using Early Treatment of Diabetic Retinopathy Study chart
Exclusion Criteria:
Have a known allergy and/or sensitivity to the test article(s) or its components or any therapies associated with the trial
Have active signs or symptoms of any clinically significant ocular disorder (other than refractive disorders)
Have a known bleeding disorder or history of bleeding complications after surgical or dental procedures
Take aspirin, or take any other blood thinners or anti-coagulants (e.g. warfarin) including prescription, over the counter, or homeopathic therapies
Have undergone any ocular surgical intervention within 3 months prior to Visit 1 or anticipate having ocular surgery during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Haque
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19108788
Citation
Torkildsen G, O'Brien TP. Conjunctival tissue pharmacokinetic properties of topical azithromycin 1% and moxifloxacin 0.5% ophthalmic solutions: a single-dose, randomized, open-label, active-controlled trial in healthy adult volunteers. Clin Ther. 2008 Nov;30(11):2005-14. doi: 10.1016/j.clinthera.2008.10.020.
Results Reference
derived
Learn more about this trial
Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers
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