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Trial record 7 of 20 for:    "Lens Disease" | "Estradiol"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by:
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE December 12, 2007
First Posted Date  ICMJE December 18, 2007
Results First Submitted Date  ICMJE June 9, 2009
Results First Posted Date  ICMJE September 16, 2009
Last Update Posted Date September 22, 2011
Study Start Date  ICMJE December 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2010)
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  ICMJE
 (submitted: December 14, 2007)
Assessment of pharmacokinetic parameters [ Time Frame: Up to 14 days ]
Change History Complete list of historical versions of study NCT00575380 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Bacterial Infections
  • Eye Infections
  • Cataract Extraction
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2009)
116
Original Estimated Enrollment  ICMJE
 (submitted: December 14, 2007)
120
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00575380
Other Study ID Numbers  ICMJE 041-103
P08655
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mike Schiewe, Inspire Pharmaceuticals
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Reza Haque, MD Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP