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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 0.5% moxifloxacin hydrochloride ophthalmic solution; Drug: 0.3% gatifloxacin ophthalmic solution; Drug: 1.5% levofloxacin ophthalmic solution

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Vistakon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Concentration of levofloxacin, moxifloxacin or gatifloxacin in tears	15 minutes, 2, 6, 12 and 24 hours

Collaborators and Investigators

• Sponsor: Santen Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: June 19, 2008
• First Submitted That Met QC Criteria: June 20, 2008
• First Posted (Estimate): June 23, 2008

Study Record Updates

• Last Update Posted (Estimate): February 6, 2009
• Last Update Submitted That Met QC Criteria: February 4, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Study drug concentration in human tears
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ophthalmic Solutions; Pharmaceutical Solutions; Levofloxacin; Ofloxacin; Gatifloxacin
• Other Study ID Numbers: VPH0108