CClinicalTrials.gg
Sign In
TerminatedNCT00764582Updated Aug 26, 2009

Ocular Penetration of 1.5% Levofloxacin and 0.5% Moxifloxacin During Corneal Transplant Surgery

A Phase 4 interventional study of 1.5% levofloxacin ophthalmic solution and 0.5% moxifloxacin ophthalmic solution in Corneal Transplantation, sponsored by Santen Inc.. Terminated at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-08-26.

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

Why this study was terminated
Study terminated due to lack of enrollment.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Compare the corneal penetration of levofloxacin 1.5% and moxifloxacin 0.5% in patients undergoing penetrating keratoplasty (PK)

02

Conditions studied

  • Corneal Transplantation

Keywords

  • Corneal penetration of levofloxacin and moxifloxacin
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
No

Inclusion criteria

  • Man or woman 18 years of age or older
  • Scheduled for corneal transplant surgery
  • Patients must be healthy enough to undergo surgery
  • Women must be postmenopausal for at least 1 year or surgically sterile incapable of pregnancy
  • Women must be abstinent at the discretion of the investigator
  • Women practicing an effective method of birth control
  • Women agree before entry to continue to use the same method of contraception throughout the study
  • Women of childbearing potential must have a negative urine pregnancy test at screening

Exclusion criteria

Exclusion Criteria

  • Presence of an active ocular infection or positive history of ocular herpetic infection
  • History of severe dry eye syndrome
  • Use of contact lenses in the 2 weeks prior to the study and for the duration of the study
  • Received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment
  • Pregnant or breast feeding
  • Employees of the investigator or study center with direct involvement in the 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
60 participants (estimated)

Study arms

  • Experimental
    1

    Drug: 1.5% levofloxacin ophthalmic solution

  • Active comparator
    2

    Drug: 0.5% moxifloxacin ophthalmic solution

Interventions

  • Drug1.5% levofloxacin ophthalmic solution

    Topical application Instill 1 drop two times, 5 minutes apart. Time from last drop to surgery is determined by group. Group 1: 30 minutes prior to surgery Group 2: 1 hour prior to surgery Group 3: 2 hours prior to surgery Group 4: 4 hours prior to surgery

    Also known as: IQUIX

  • Drug0.5% moxifloxacin ophthalmic solution

    Topical application Instill 1 drop two times, 5 minutes apart. Time from last drop to surgery is determined by group. Group 5: 30 minutes prior to surgery Group 6: 1 hour prior to surgery Group 7: 2 hours prior to surgery Group 8: 4 hours prior to surgery

    Also known as: VIGAMOX

06

What researchers measure

Primary outcomes

  1. Concentration of levofloxacin and moxifloxacin in the corneal tissue

    Time frame: Time of surgery

Secondary outcomes

  1. Adverse Events

    Time frame: 4 days

07

Study locations

8 sites
  • Boynton Beach, Florida, United States
  • Indianapolis, Indiana, United States
  • Great Rapids, Michigan, United States
  • Kansas City, Missouri, United States
  • Springfield, Missouri, United States
  • Stony Brook, New York, United States
  • Cincinnati, Ohio, United States
  • Portland, Oregon, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00764582
Lead sponsor
Santen Inc.
Collaborators
Vistakon Pharmaceuticals
First posted
Oct 2, 2008
Start date
Sep 2008
Primary completion
Mar 2009 (estimated)
Last update
Aug 26, 2009

Oversight

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

Not currently enrolling

This study is terminated, as verified in Aug 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.

Other studies in this condition

Eye Injuries, Penetrating

Other studies from this sponsor

Santen Inc.

Start the discussion