Back to resultsStudy of AzaSite Versus Vigamox in the Tears of Healthy Volunteers
Primary Purpose
Bacterial Infections, Eye Infections
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AzaSite (azithromycin ophthalmic solution)
Vigamox (moxifloxacin hydrochloride ophthalmic solution)
Sponsored by
About this trial
This is an interventional supportive care trial for Bacterial Infections
Eligibility Criteria
Inclusion Criteria:
- Have visual acuity, using corrective lenses (no contact lenses) if necessary, in both eyes of at least +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study.
- Have normal lid anatomy.
Exclusion Criteria:
- Have an abnormal biomicroscopy or ophthalmoscopy exam.
- Have a diagnosis of dry eye disease or have experienced any of the dry eye symptoms (photophobia, foreign body sensation, itching, burning, pain, dry or grittiness) in the past thirty days.
- Have used artificial tears in the past thirty days.
- Have a diagnosis of on-going ocular infection or lid margin inflammation.
- Have ever had penetrating ocular surface or intraocular surgery.
- Have a known hypersensitivity to azithromycin, or any macrolide antibiotic or to any of the ingredients in AzaSite.
- Have had a known hypersensitivity to Vigamox or any fluoroquinolone antibiotics or to any of the ingredients in Vigamox.
- Have had corneal or lid abnormalities.
- Have glaucoma, or Intra Ocular Pressure of 22 mm Hg or greater in one or both eyes.
- Have any ocular pathology with the exception of cataracts.
- Have a serious systemic disease or uncontrolled medical condition.
- Have experienced symptoms of viral or allergic conjunctivitis in the past 30 days.
- Have a history of liver or kidney disease resulting in persisting dysfunction.
Sites / Locations
- Mount Sinai School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
AzaSite
Vigamox
Arm Description
Outcomes
Primary Outcome Measures
Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.
Secondary Outcome Measures
Full Information
NCT ID
NCT00575367
First Posted
December 14, 2007
Last Updated
September 20, 2011
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00575367
Brief Title
Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers
Official Title
A Single-Center, Open-Label, Randomized Study of the Pharmacokinetics of AzaSite Ophthalmic Solution Versus Vigamox in the Tears 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
March 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears 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
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AzaSite
Arm Type
Active Comparator
Arm Title
Vigamox
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
AzaSite (azithromycin ophthalmic solution)
Intervention Description
One drop ophthalmic solution at Visit 2
Intervention Type
Drug
Intervention Name(s)
Vigamox (moxifloxacin hydrochloride ophthalmic solution)
Intervention Description
One drop ophthalmic solution at Visit 2
Primary Outcome Measure Information:
Title
Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.
Time Frame
15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Have visual acuity, using corrective lenses (no contact lenses) if necessary, in both eyes of at least +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study.
Have normal lid anatomy.
Exclusion Criteria:
Have an abnormal biomicroscopy or ophthalmoscopy exam.
Have a diagnosis of dry eye disease or have experienced any of the dry eye symptoms (photophobia, foreign body sensation, itching, burning, pain, dry or grittiness) in the past thirty days.
Have used artificial tears in the past thirty days.
Have a diagnosis of on-going ocular infection or lid margin inflammation.
Have ever had penetrating ocular surface or intraocular surgery.
Have a known hypersensitivity to azithromycin, or any macrolide antibiotic or to any of the ingredients in AzaSite.
Have had a known hypersensitivity to Vigamox or any fluoroquinolone antibiotics or to any of the ingredients in Vigamox.
Have had corneal or lid abnormalities.
Have glaucoma, or Intra Ocular Pressure of 22 mm Hg or greater in one or both eyes.
Have any ocular pathology with the exception of cataracts.
Have a serious systemic disease or uncontrolled medical condition.
Have experienced symptoms of viral or allergic conjunctivitis in the past 30 days.
Have a history of liver or kidney disease resulting in persisting dysfunction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Haque, MD
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers
We'll reach out to this number within 24 hrs