Ocular Tissue Levels of 1.5% Levofloxacin Ophthalmic Solution Compared to an Active Comparator

Compare ocular tissue levels following topical ocular instillation of 1.5% levofloxacin ophthalmic solution or an active comparator in subjects undergoing cataract surgery.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Wilkes-Barre, Pennsylvania, United States, 18702
      • Bucci Laser Vision & Ambulatory Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Capable of instilling eye drop
• Scheduled for cataract surgery with intraocular lens (IOL) implantation
• Be medically cleared for surgery
• Women must be postmenopausal (for at least 1 year), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry, and must agree 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.
• Willing to adhere to the prohibitions and restrictions specified in this protocol.
• Subjects (or his/her legally acceptable representative) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

• Known allergy or other contraindication to the test article(s) or their components.
• Presence of any abnormality or significant illness in the eye that in the investigator's opinion could affect the subject's health or the study parameters.
• History of or presence of any corneal pathology or disease
• Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection.
• History of severe dry eye syndrome.
• History or evidence of previous ocular surgery in the operative eye.
• History of any significant illness that could be expected to interfere with the study parameters.

• Use of disallowed therapies (systemic or topical):

  • Fluoroquinolone anti-infective agents (systemic or topical) within 2 weeks of Visit 1 or anytime after Visit 1 for the duration of the study;
  • Topical ophthalmic preparations (including tear substitutes and rewetting drops), within 1 week of Visit 1 or anytime after Visit 1 for the duration of the study (other than the study medication as restricted above), with the exception of non-steroidal topical ophthalmic drops
• 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.
• Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 2	Drug: 0.5% moxifloxacin hydrochloride ophthalmic solution; Topical application
EXPERIMENTAL: 1	Drug: 1.5% levofloxacin ophthalmic solution; Topical application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Concentration of levofloxacin and active control in the aqueous humor	Time of surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse Events	4 days

Collaborators and Investigators

• Sponsor: Santen Inc.
• Collaborators: Vistakon Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (ACTUAL): October 1, 2008

Study Registration Dates

• First Submitted: February 22, 2008
• First Submitted That Met QC Criteria: March 5, 2008
• First Posted (ESTIMATE): March 6, 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: Aqueous humor penetration by anti-infectives
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; 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
• Other Study ID Numbers: VPH0107