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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cataract Extraction	Drug: Besifloxacin hydrochloride; Drug: moxifloxacin hydrochloride; Drug: gatifloxacin	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• 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
• Study Start Date: February 2009
• Actual Primary Completion Date: July 2009
• Actual Study Completion Date: August 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Besifloxacin; Besifloxacin ophthalmic suspension	Drug: Besifloxacin hydrochloride; Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.; Other Name: Besivance
Active Comparator: Moxifloxacin; Vigamox (moxifloxacin ophthalmic solution, 0.5%)	Drug: moxifloxacin hydrochloride; Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.; Other Name: Vigamox
Active Comparator: Gatifloxacin; Zymar (gatifloxacin ophthalmic solution, 0.3%)	Drug: gatifloxacin; Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.; Other Name: Zymar

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New York

Ophthalmic Consultants of Long Island

Rockville Center, New York, United States, 11570

Sponsors and Collaborators

Bausch & Lomb Incorporated

Investigators

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

More Information

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00824070 History of Changes
• Other Study ID Numbers: 575
• First Posted: January 16, 2009
• Results First Posted: October 29, 2010
• Last Update Posted: December 13, 2011
• Last Verified: December 2011

Keywords provided by Bausch & Lomb Incorporated:

Bioavailability

Additional relevant MeSH terms:

Cataract; Lens Diseases; Eye Diseases; Moxifloxacin; Gatifloxacin; Besifloxacin; Fluoroquinolones; Norgestimate, ethinyl estradiol drug combination; Anti-Bacterial Agents; Anti-Infective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Ophthalmic Solutions; Pharmaceutical Solutions; Nucleic Acid Synthesis Inhibitors