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

NCT00905762 | Completed Phase 1

• 1 other identifier: 608
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

pharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (2)

• Visual acuity

  Day -14 through Day 6(+/-1)

• Slit Lamp Biomicroscopy

  Day -14 through Day 6 (+/-)

Study Arms (3)

Besifloxacin

EXPERIMENTAL

Besifloxacin one drop instilled into study eye.

Drug: Besifloxacin

Gatifloxacin

ACTIVE COMPARATOR

Gatifloxacin one drop instilled into study eye.

Drug: Gatifloxacin

Moxifloxacin

ACTIVE COMPARATOR

Moxifloxacin one drop instilled into study eye.

Drug: Moxifloxacin

Interventions

Gatifloxacin DRUG

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

Gatifloxacin

Moxifloxacin DRUG

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

Moxifloxacin

Besifloxacin DRUG

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

Also known as: Besivance

Besifloxacin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb Incorporated

Rochester, New York, 14609, United States

Location

MeSH Terms

Interventions

Gatifloxacin; Moxifloxacin; besifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Timothy Comstock, OD

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2009
• First Posted: May 21, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 9, 2011

Record last verified: 2011-12

Locations

US (1)