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Sponsored by: |
Santen Inc. |
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Information provided by: | Santen Inc. |
ClinicalTrials.gov Identifier: | NCT00703313 |
The primary objective of this study is to compare the concentration in human tears of levofloxacin and the active comparators at 15 minutes, 2,6, 12, and 24 hours after instillation of a single drop of medication.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: 1.5% levofloxacin ophthalmic solution Drug: 0.5% moxifloxacin hydrochloride ophthalmic solution Drug: 0.3% gatifloxacin ophthalmic solution |
Phase IV |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Single Blind (Investigator), Dose Comparison, Parallel Assignment, Pharmacokinetics Study |
Estimated Enrollment: | 72 |
Study Start Date: | May 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
2: Active Comparator
described in intervention
|
Drug: 0.5% moxifloxacin hydrochloride ophthalmic solution
1 drop instilled at each visit
|
3: Active Comparator
described in intervention
|
Drug: 0.3% gatifloxacin ophthalmic solution
1 drop instilled at each visit
|
1: Active Comparator
described in intervention
|
Drug: 1.5% levofloxacin ophthalmic solution
1 drop instilled at each visit
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | VISTAKON Pharmaceuticals ( Brian Schwam, MD/Medical Director ) |
Study ID Numbers: | VPH0108 |
Study First Received: | June 19, 2008 |
Last Updated: | February 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00703313 History of Changes |
Health Authority: | United States: Institutional Review Board |
Study drug concentration in human tears |
Lacerations Anti-Bacterial Agents Fluoroquinolones Moxifloxacin |
Ofloxacin Anti-Infective Agents, Urinary Healthy Gatifloxacin |
Anti-Infective Agents Fluoroquinolones Molecular Mechanisms of Pharmacological Action Ofloxacin Enzyme Inhibitors Anti-Infective Agents, Urinary Renal Agents |
Pharmacologic Actions Gatifloxacin Anti-Bacterial Agents Moxifloxacin Therapeutic Uses Nucleic Acid Synthesis Inhibitors |