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Completed

NCT Number: NCT00905762

Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation

The purpose of this study is to assess the concentration of besifloxacin compared to gatifloxacin and moxifloxacin in human conjunctival tissue, following a single drop of the drug instilled topically into the study eye. Conjunctival biopsies will be performed at specified time points, followed by the use of loteprednol etabonate/tobramycin ophthalmic suspension four times a day for 5 days.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bausch & Lomb Incorporated

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Willing to avoid all disallowed medications for the appropriate washout periods.
  • Have a best corrected visual acuity of 0.60 logMAR or better in each eye as measured using an ETDRS chart.

Exclusion criteria

  • Have a known allergy and/or sensitivity to the test articles or its components or any therapy associated with the trial.
  • Monocular.
  • Have previously participated in a conjunctival biopsy study.
  • Be currently enrolled in an investigational drug or device study or have uses of an investigational drug or device within 30 days of entry into this study.
  • have a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

Treatment and study plan

Gatifloxacin

Drug

Gatifloxacin 0.3% one drop instilled into study eye at visit 2.

moxifloxacin

Drug

Moxifloxacin 0.5% one drop instilled into study eye at visit 2.

Besifloxacin

Drug

Besifloxacin 0.6% one drop instilled into study eye at visit 2.

Other names: Besivance

Primary outcomes

  1. Concentration of besifloxacin, gatifloxacin or moxifloxacin in conjunctival tissue.

    Time frame: Biopsies collected at specified time points from 15 minutes to 24 hours

Secondary outcomes

  1. Visual acuity

    Time frame: Day -14 through Day 6(+/-1)

  2. Slit Lamp Biomicroscopy

    Time frame: Day -14 through Day 6 (+/-)

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

A Single-Center, Randomized, Masked Study Comparing the Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After a Single Topical Instillation

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 21, 2009
Registry last updated
Dec 9, 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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