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Completed

NCT Number: NCT00824070

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

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.

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Key information

Conditions

Cataract Extraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ophthalmic Consultants of Long Island

Rockville Centre, New York, 11570, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Besifloxacin hydrochloride

Drug

Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.

Other names: Besivance

Moxifloxacin Hydrochloride

Drug

Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.

Other names: Vigamox

Gatifloxacin

Drug

Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.

Other names: Zymar

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 16, 2009
Registry last updated
Dec 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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