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

Bausch + Lomb

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Gatifloxacin; Drug: Moxifloxacin; Drug: Besifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00905762

608

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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119 participants in 3 patient groups

Besifloxacin

Experimental group

Description:

Besifloxacin one drop instilled into study eye.

Treatment:

Drug: Besifloxacin

Gatifloxacin

Active Comparator group

Description:

Gatifloxacin one drop instilled into study eye.

Treatment:

Drug: Gatifloxacin

Moxifloxacin

Active Comparator group

Description:

Moxifloxacin one drop instilled into study eye.

Treatment:

Drug: Moxifloxacin