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Trial record 8 of 19 for:    "Lens Disease" | "Estradiol"

Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects

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ClinicalTrials.gov Identifier: NCT00824070
Recruitment Status : Completed
First Posted : January 16, 2009
Results First Posted : October 29, 2010
Last Update Posted : December 13, 2011
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Tracking Information
First Submitted Date  ICMJE January 15, 2009
First Posted Date  ICMJE January 16, 2009
Results First Submitted Date  ICMJE September 30, 2010
Results First Posted Date  ICMJE October 29, 2010
Last Update Posted Date December 13, 2011
Study Start Date  ICMJE February 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2010)
The Aqueous Humor Drug Concentration. [ Time Frame: Visit 2, 1-14 days following screening visit ]
An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2009)
The Aqueous Humor Drug Concentration. [ Time Frame: Following cataract extraction surgery ]
Change History Complete list of historical versions of study NCT00824070 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2009)
The difference, between subjects treated with besifloxacin ophthalmic suspension and subjects treated with active control, in the mean AH drug concentration. [ Time Frame: Following cataract extraction surgery. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects
Official Title  ICMJE An Open-Label, Randomized Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects After a Single Topical Dose
Brief Summary This study is being conducted to assess the concentration of besifloxacin, moxifloxacin, or gatifloxacin in aqueous humor samples collected following topical instillation of the associated formulation in subjects undergoing cataract surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Cataract Extraction
Intervention  ICMJE
  • Drug: Besifloxacin hydrochloride
    Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
    Other Name: Besivance
  • Drug: moxifloxacin hydrochloride
    Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
    Other Name: Vigamox
  • Drug: gatifloxacin
    Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
    Other Name: Zymar
Study Arms  ICMJE
  • Experimental: Besifloxacin
    Besifloxacin ophthalmic suspension
    Intervention: Drug: Besifloxacin hydrochloride
  • Active Comparator: Moxifloxacin
    Vigamox (moxifloxacin ophthalmic solution, 0.5%)
    Intervention: Drug: moxifloxacin hydrochloride
  • Active Comparator: Gatifloxacin
    Zymar (gatifloxacin ophthalmic solution, 0.3%)
    Intervention: Drug: gatifloxacin
Publications * Not Provided

*   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: January 15, 2009)
105
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who are a candidate for a routine, uncomplicated, primary cataract extraction.
  • Subjects who, in the Investigator's opinion, have potential for postoperative best corrected Snellen visual acuity of at least 20/200 in the study eye.

Exclusion Criteria:

  • Subjects who have a known sensitivity, contraindication, or allergy to the study medication(s) or their components.
  • Subjects who had any corneal refractive surgery in the study eye.
  • Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
  • Subjects who had ocular surgery in the study eye, including laser procedures, within the past 6 months.
  • Subjects who have taken any topical ocular medication in the study eye, other than those required by the protocol and permitted for surgery, during the 24 hours prior to the study medication being instilled.
  • Subjects who use any antibiotics (e.g., systemic or topical) within the 7 days prior to the surgery date.
  • Subjects who are monocular.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT00824070
Other Study ID Numbers  ICMJE 575
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bausch & Lomb Incorporated
Study Sponsor  ICMJE Bausch & Lomb Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Donnefeld Ophthalmic Consultants of Long Island
PRS Account Bausch & Lomb Incorporated
Verification Date December 2011

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