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Ocular Availability in Human Tears After Topical Administration of 1.5% Levofloxacin Compared to Active Comparators

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00703313
Recruitment Status : Completed
First Posted : June 23, 2008
Last Update Posted : February 6, 2009
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: 1.5% levofloxacin ophthalmic solution Drug: 0.5% moxifloxacin hydrochloride ophthalmic solution Drug: 0.3% gatifloxacin ophthalmic solution Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Study Start Date : May 2008
Primary Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 2
described in intervention
Drug: 0.5% moxifloxacin hydrochloride ophthalmic solution
1 drop instilled at each visit
Active Comparator: 3
described in intervention
Drug: 0.3% gatifloxacin ophthalmic solution
1 drop instilled at each visit
Active Comparator: 1
described in intervention
Drug: 1.5% levofloxacin ophthalmic solution
1 drop instilled at each visit

Outcome Measures

Primary Outcome Measures :
  1. Concentration of levofloxacin, moxifloxacin or gatifloxacin in tears [ Time Frame: 15 minutes, 2, 6, 12 and 24 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Be willing and able to provide written informed consent and HIPAA indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
  • Be willing and able to follow all instructions and attend all study visits
  • If female and of childbearing potential, not be pregnant, nursing or planning a pregnancy and agree to submit to a pregnancy test. The result of the test must be negative and female subjects of childbearing potential must also agree to use an acceptable method of contraception for the duration of the study (acceptable method of contraception includes oral, implantable, transdermal, or injectible contraceptives, spermicide with barrier, IUD, or surgical sterilization of partner)

Exclusion Criteria:

  • Have a known allergy and/or sensitivity to the test article(s) or its components or any therapies associated with the study
  • Have active signs or symptoms of any clinically significant ocular disorder (other than refractive disorders)
  • Have a history of dry eye syndrome
  • Use disallowed medications (systemic or topical) (i.e. any fluoroquinolone anti-infective agents or any topical ophthalmic products) during the appropriate pre-study washout period and during the study.
  • Be a contact lens wearer who is unwilling to forego contact lens wear within 3 days prior to the start of the study and for the duration of the study
  • Have had any ocular surgical intervention 12 months prior to the study or anticipate having ocular surgery during the study
  • Be pregnant or nursing women; or women who have a positive urine pregnancy test at screening or women of childbearing potential who refuse to use an adequate hormonal or mechanical means of birth control
  • Be concurrently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of entry into this study
  • Employees of the investigator or study center, with direct involvement in th proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Contacts and Locations

Information from the National Library of Medicine

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): NCT00703313

United States, Florida
Jacksonville, Florida, United States, 32256
Sponsors and Collaborators
Santen Inc.
More Information

Responsible Party: Brian Schwam, MD/Medical Director, VISTAKON Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00703313     History of Changes
Other Study ID Numbers: VPH0108
First Posted: June 23, 2008    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009

Keywords provided by Santen Inc.:
Study drug concentration in human tears

Additional relevant MeSH terms:
Pharmaceutical Solutions
Ophthalmic Solutions
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Infective Agents, Urinary
Renal Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors