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

This study has been completed.
Sponsor:
Information provided by:
Santen Inc.
ClinicalTrials.gov Identifier:
NCT00703313
First received: June 19, 2008
Last updated: February 4, 2009
Last verified: February 2009
History of Changes
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Santen Inc.:

Primary Outcome Measures:
  • Concentration of levofloxacin, moxifloxacin or gatifloxacin in tears [ Time Frame: 15 minutes, 2, 6, 12 and 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: May 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703313

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

No publications provided

Responsible Party: Brian Schwam, MD/Medical Director, VISTAKON Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00703313     History of Changes
Other Study ID Numbers: VPH0108
Study First Received: June 19, 2008
Last Updated: February 4, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Ofloxacin
Fluoroquinolones
Gatifloxacin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013