Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation
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ClinicalTrials.gov Identifier: NCT00905762 |
Recruitment Status :
Completed
First Posted : May 21, 2009
Last Update Posted : December 9, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Gatifloxacin Drug: Moxifloxacin Drug: Besifloxacin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 119 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Screening |
Official Title: | A Single-Center, Randomized, Masked Study Comparing the Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After a Single Topical Instillation |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | April 2009 |
Actual Study Completion Date : | April 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Besifloxacin
Besifloxacin one drop instilled into study eye.
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Drug: Besifloxacin
Besifloxacin 0.6% one drop instilled into study eye at visit 2.
Other Name: Besivance |
Active Comparator: Gatifloxacin
Gatifloxacin one drop instilled into study eye.
|
Drug: Gatifloxacin
Gatifloxacin 0.3% one drop instilled into study eye at visit 2. |
Active Comparator: Moxifloxacin
Moxifloxacin one drop instilled into study eye.
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Drug: Moxifloxacin
Moxifloxacin 0.5% one drop instilled into study eye at visit 2. |
- Concentration of besifloxacin, gatifloxacin or moxifloxacin in conjunctival tissue. [ Time Frame: Biopsies collected at specified time points from 15 minutes to 24 hours ]
- Visual acuity [ Time Frame: Day -14 through Day 6(+/-1) ]
- Slit Lamp Biomicroscopy [ Time Frame: Day -14 through Day 6 (+/-) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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): NCT00905762
United States, New York | |
Bausch & Lomb Incorporated | |
Rochester, New York, United States, 14609 |
Study Director: | Timothy Comstock, OD | Bausch & Lomb Incorporated |
Responsible Party: | Bausch & Lomb Incorporated |
ClinicalTrials.gov Identifier: | NCT00905762 |
Other Study ID Numbers: |
608 |
First Posted: | May 21, 2009 Key Record Dates |
Last Update Posted: | December 9, 2011 |
Last Verified: | December 2011 |
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