Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers
Information source: Inspire Pharmaceuticals
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Infections; Eye Infections
Intervention: AzaSite (azithromycin ophthalmic solution) (Drug); Vigamox (moxifloxacin hydrochloride ophthalmic solution) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Inspire Pharmaceuticals Official(s) and/or principal investigator(s):
Reza Haque, MD, Study Director, Affiliation: Inspire Pharmaceuticals
Summary
The purpose of this study is to evaluate the drug concentrations of AzaSite compared to
Vigamox in tears of healthy volunteers
Clinical Details
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 design: Supportive Care, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Assessment of pharmacokinetic parameters
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 artifical 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.
Locations and Contacts
Mount Sinai School of Medicine, New York, New York 10029, United States; Recruiting
Morgan Massingale, MS, Phone: 212-241-8823, Email: morgan.massingale@mssm.edu
Additional Information
Starting date: March 2008
Last updated: June 4, 2008
|
