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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Corneal Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Group Type EXPERIMENTAL

1.5% levofloxacin ophthalmic solution

Intervention Type DRUG

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

2

Group Type ACTIVE_COMPARATOR

0.5% moxifloxacin ophthalmic solution

Intervention Type DRUG

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

Interventions

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1.5% 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

Intervention Type DRUG

0.5% 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

Intervention Type DRUG

Other Intervention Names

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IQUIX VIGAMOX

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No