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

NCT00703313 | Completed Phase 4

• 1 other identifier: VPH0108
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Study drug concentration in human tears

Outcome Measures

Primary Outcomes (1)

• Concentration of levofloxacin, moxifloxacin or gatifloxacin in tears

  15 minutes, 2, 6, 12 and 24 hours

Study Arms (3)

2

ACTIVE COMPARATOR

described in intervention

Drug: 0.5% moxifloxacin hydrochloride ophthalmic solution

3

ACTIVE COMPARATOR

described in intervention

Drug: 0.3% gatifloxacin ophthalmic solution

1

ACTIVE COMPARATOR

described in intervention

Drug: 1.5% levofloxacin ophthalmic solution

Interventions

0.3% gatifloxacin ophthalmic solution DRUG

1 drop instilled at each visit

3

1.5% levofloxacin ophthalmic solution DRUG

1 drop instilled at each visit

1

0.5% moxifloxacin hydrochloride ophthalmic solution DRUG

1 drop instilled at each visit

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Santen Inc.: lead

Study Sites (1)

Vistakon

Jacksonville, Florida, 32256, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 23, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2008
• Last Updated: February 6, 2009

Record last verified: 2009-02

Locations

US (1)