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

• 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: Bausch & Lomb Incorporated
• Information provided by (Responsible Party): Bausch & Lomb Incorporated

Tracking Information

• First Submitted Date: January 15, 2009
• First Posted Date: January 16, 2009
• Results First Submitted Date: September 30, 2010
• Results First Posted Date: October 29, 2010
• Last Update Posted Date: December 13, 2011
• Study Start Date: February 2009
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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: Not Provided
• Original Secondary Outcome Measures (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: Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Screening
• Condition: Cataract Extraction

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 15, 2009): 105
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2009
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00824070
• Other Study ID Numbers: 575
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Bausch & Lomb Incorporated
• Study Sponsor: Bausch & Lomb Incorporated
• Collaborators: Not Provided

Investigators

• Principal Investigator: Eric Donnefeld; Ophthalmic Consultants of Long Island

• PRS Account: Bausch & Lomb Incorporated
• Verification Date: December 2011