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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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824070


Locations
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United States, New York
Ophthalmic Consultants of Long Island
Rockville Center, New York, United States, 11570
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Principal Investigator: Eric Donnefeld Ophthalmic Consultants of Long Island

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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00824070     History of Changes
Other Study ID Numbers: 575
First Posted: January 16, 2009    Key Record Dates
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:
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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