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

This study has been completed.
Sponsor:
Collaborator:
Vistakon Pharmaceuticals
Information provided by:
Santen Inc.
ClinicalTrials.gov Identifier:
NCT00630019
First received: February 22, 2008
Last updated: February 4, 2009
Last verified: February 2009
  Purpose

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


Condition Intervention Phase
Cataract
Drug: 1.5% levofloxacin ophthalmic solution
Drug: 0.5% moxifloxacin hydrochloride ophthalmic solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Santen Inc.:

Primary Outcome Measures:
  • Concentration of levofloxacin and active control in the aqueous humor [ Time Frame: Time of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 96
Study Start Date: February 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: 1.5% levofloxacin ophthalmic solution
Topical application
Active Comparator: 2 Drug: 0.5% moxifloxacin hydrochloride ophthalmic solution
Topical application

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630019

Locations
United States, Pennsylvania
Bucci Laser Vision & Ambulatory Surgery Center
Wilkes-Barre, Pennsylvania, United States, 18702
Sponsors and Collaborators
Santen Inc.
Vistakon Pharmaceuticals
  More Information

No publications provided

Responsible Party: Brian Schwam, MD, VISTAKON Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00630019     History of Changes
Other Study ID Numbers: VPH0107
Study First Received: February 22, 2008
Last Updated: February 4, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Santen Inc.:
Aqueous humor penetration by anti-infectives

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Ophthalmic Solutions
Levofloxacin
Ofloxacin
Moxifloxacin
Pharmaceutical Solutions
Norgestimate, ethinyl estradiol drug combination
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014