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”

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

Study Type: Interventional

Study Design: Supportive Care, Randomized, Open Label, Parallel Assignment

Study Primary Completion Date: December 2007

Intervention(s) in this Clinical Trial

• Drug: AzaSite (azithromycin ophthalmic solution)
  • One drop ophthalmic solution at Visit 2 (Day 0)
• Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)
  • One drop ophthalmic solution at Visit 2 (Day 0)

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 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

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 Study Director Inspire Pharmaceuticals  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00564447

Study ID Number: 041-102

ClinicalTrials.gov Identifier: NCT00564447

Health Authority: United States: Food and Drug Administration