Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT00575367|
Recruitment Status : Completed
First Posted : December 18, 2007
Results First Posted : September 17, 2009
Last Update Posted : September 22, 2011
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|Condition or disease||Intervention/treatment||Phase|
|Bacterial Infections Eye Infections||Drug: AzaSite (azithromycin ophthalmic solution) Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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 Start Date :||March 2008|
|Actual Primary Completion Date :||October 2008|
|Active Comparator: AzaSite||
Drug: AzaSite (azithromycin ophthalmic solution)
One drop ophthalmic solution at Visit 2
|Active Comparator: Vigamox||
Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)
One drop ophthalmic solution at Visit 2
- 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 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575367
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Study Director:||Reza Haque, MD||Merck Sharp & Dohme LLC|
|Responsible Party:||Karen Kuhn, Inspire Pharmaceuticals, Inc.|
|Other Study ID Numbers:||
|First Posted:||December 18, 2007 Key Record Dates|
|Results First Posted:||September 17, 2009|
|Last Update Posted:||September 22, 2011|
|Last Verified:||September 2011|
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