Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers

• ClinicalTrials.gov Identifier: NCT00575367
• Recruitment Status: Completed
• First Posted: December 18, 2007
• Results First Posted: September 17, 2009
• Last Update Posted: September 22, 2011
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by: Merck Sharp & Dohme LLC

Tracking Information

• First Submitted Date: December 14, 2007
• First Posted Date: December 18, 2007
• Results First Submitted Date: August 10, 2009
• Results First Posted Date: September 17, 2009
• Last Update Posted Date: September 22, 2011
• Study Start Date: March 2008
• Actual Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 4, 2009): 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 ]
• Original Primary Outcome Measures (submitted: December 14, 2007): Assessment of pharmacokinetic parameters [ Time Frame: Up to 24 hours ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Brief Summary: The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Bacterial Infections
• Eye Infections

Intervention

• 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

Study Arms

• Active Comparator: AzaSite
  Intervention: Drug: AzaSite (azithromycin ophthalmic solution)
• Active Comparator: Vigamox
  Intervention: Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 11, 2009): 37
• Original Estimated Enrollment (submitted: December 14, 2007): 36
• Study Completion Date: Not Provided
• Actual Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00575367
• Other Study ID Numbers: 041-101; P08653
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Karen Kuhn, Inspire Pharmaceuticals, Inc.
• Original Responsible Party: Saiid Davari, BS, Inspire Pharmaceuticals, Inc.
• Current Study Sponsor: Merck Sharp & Dohme LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Reza Haque, MD; Merck Sharp & Dohme LLC

• PRS Account: Merck Sharp & Dohme LLC
• Verification Date: September 2011