CClinicalTrials.gg
CompletedNCT00703313Updated Feb 6, 2009

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

A Phase 4 interventional study of 1.5% levofloxacin ophthalmic solution and 0.5% moxifloxacin hydrochloride ophthalmic solution in Healthy, sponsored by Santen Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-02-06.

Sponsored by Santen Inc. · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • Study drug concentration in human tears
03

In context

Lead sponsor

Santen Inc. is the lead sponsor of 31 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
72 participants (estimated)

Study arms

  • Active comparator
    2

    described in intervention

    Drug: 0.5% moxifloxacin hydrochloride ophthalmic solution

  • Active comparator
    3

    described in intervention

    Drug: 0.3% gatifloxacin ophthalmic solution

  • Active comparator
    1

    described in intervention

    Drug: 1.5% levofloxacin ophthalmic solution

Interventions

  • Drug1.5% levofloxacin ophthalmic solution

    1 drop instilled at each visit

  • Drug0.5% moxifloxacin hydrochloride ophthalmic solution

    1 drop instilled at each visit

  • Drug0.3% gatifloxacin ophthalmic solution

    1 drop instilled at each visit

06

What researchers measure

Primary outcomes

  1. Concentration of levofloxacin, moxifloxacin or gatifloxacin in tears

    Time frame: 15 minutes, 2, 6, 12 and 24 hours

07

Study locations

1 site
  • Vistakon
    Jacksonville, Florida 32256, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00703313
Lead sponsor
Santen Inc.
First posted
Jun 23, 2008
Start date
May 2008
Primary completion
Jun 2008
Last update
Feb 6, 2009

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion