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”

The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers

Study Type: Interventional

Study Design: Supportive Care, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• Drug: AzaSite (azithromycin ophthalmic solution)
  • One drop ophthalmic solution at Visit 2
• Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)
  • One drop ophthalmic solution at Visit 2

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 2

Primary Measures

• Assessment of pharmacokinetic parameters
  • Time Frame: Up to 24 hours
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Inspire Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Reza Haque, MD Study Director Inspire Pharmaceuticals  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00575367

Study ID Number: 041-101

ClinicalTrials.gov Identifier: NCT00575367

Health Authority: United States: Food and Drug Administration