Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery

• ClinicalTrials.gov Identifier: NCT00575380
• Recruitment Status: Completed
• First Posted: December 18, 2007
• Results First Posted: September 16, 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 12, 2007
• First Posted Date: December 18, 2007
• Results First Submitted Date: June 9, 2009
• Results First Posted Date: September 16, 2009
• Last Update Posted Date: September 22, 2011
• Study Start Date: December 2007
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 11, 2009)

Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) [ Time Frame: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312 ]

Nominal time is scheduled time relative to administration of the first eye drop

• Original Primary Outcome Measures (submitted: December 14, 2007): Assessment of pharmacokinetic parameters [ Time Frame: Up to 14 days ]
• Current Secondary Outcome Measures (submitted: August 11, 2009): Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) [ Time Frame: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312 ]
• 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 Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery
• Official Title: A Multi-Center, Open-Label, Randomized Study of the Pharmacokinetics of Azithromycin Versus Moxifloxacin in Conjunctiva and Aqueous Humor Following Single or Multiple Ocular Administration of AzaSite Ophthalmic Solution, 1% or Vigamox in Subjects Undergoing Routine Cataract Surgery
• Brief Summary: The purpose of this study is to evaluate the drug concentrations in the conjunctiva and aqueous humor of AzaSite™ compared to Vigamox® in subjects undergoing routine cataract surgery
• 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
• Cataract Extraction

Intervention

• Drug: AzaSite Eye Drops
  One drop two times a day for two days and once a day for the next five days.
  Other Name: AzaSite (azithromycin ophthalmic solution)
• Drug: Vigamox Eye Drops
  One drop three times a day for seven days
  Other Name: Vigamox(moxifloxacin hydrochloride ophthalmic solution)

Study Arms

• Active Comparator: AzaSite Eye Drops
  One drop two times a day for two days and once a day for the next five days
  Intervention: Drug: AzaSite Eye Drops
• Active Comparator: Vigamox Eye Drops
  One drop three times a day for seven days
  Intervention: Drug: Vigamox Eye Drops

• Publications *: Stewart WC, Crean CS, Zink RC, Brubaker K, Haque RM, Hwang DG. Pharmacokinetics of azithromycin and moxifloxacin in human conjunctiva and aqueous humor during and after the approved dosing regimens. Am J Ophthalmol. 2010 Nov;150(5):744-751.e2. doi: 10.1016/j.ajo.2010.05.039. Epub 2010 Sep 1.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 11, 2009): 116
• Original Estimated Enrollment (submitted: December 14, 2007): 120
• Study Completion Date: Not Provided
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Are scheduled to undergo routine cataract surgery by the investigator's preferred technique.
• Have normal appearing, freely mobile, conjunctiva in the inferior temporal portion cul-de-sac site of the operative eye.

Exclusion Criteria:

• Have concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
• Have a history of ocular pemphigoid.
• Have ever had penetrating ocular surface surgery.
• Have had intraocular surgery within the past 3 months.
• Have ever had prior surgery or full penetrating trauma to the conjunctiva at the proposed surgical site.
• Have a planned cataract surgery in the contraleteral eye within 2 weeks of the study related surgical procedure and sample collection.
• Have a combined procedure planned (trabeculectomy surgery planned in the same eye as cataract extraction surgery).
• Have at the proposed conjunctiva biopsy site, signs of conjunctival shortening of the fornix, scarring or adherence to the underlying episclera.
• Have according to the investigator's judgment, risk of intra- or post-operative complications related to their cataract surgery as a consequence of participation in the study.
• 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.
• Are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the ocular or systemic use of either azithromycin or moxifloxacin, when it is the same medication as the subject's assigned study drug. This relates as well, to the use of either of these medications as a pre-surgical prophylaxis.
• Are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the use of erythromycin ointment or ofloxacin.
• Have any ocular pathology with the exception of cataracts that in the judgment of the investigator could confound study assessments or limit compliance.
• Have a serious systemic disease or uncontrolled medical condition or psychiatric condition that in the judgement of the investigator could confound study assessments or limit compliance.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 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: NCT00575380
• Other Study ID Numbers: 041-103; P08655
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Mike Schiewe, Inspire Pharmaceuticals
• Original Responsible Party: Same as current
• 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