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Trial record 11 of 19 for:    "Lens Disease" | "Estradiol"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00630019
Recruitment Status : Completed
First Posted : March 6, 2008
Last Update Posted : February 6, 2009
Vistakon Pharmaceuticals
Information provided by:
Santen Inc.

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

Condition or disease Intervention/treatment Phase
Cataract Drug: 1.5% levofloxacin ophthalmic solution Drug: 0.5% moxifloxacin hydrochloride ophthalmic solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Study Start Date : February 2008
Actual Primary Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: 1 Drug: 1.5% levofloxacin ophthalmic solution
Topical application

Active Comparator: 2 Drug: 0.5% moxifloxacin hydrochloride ophthalmic solution
Topical application

Primary Outcome Measures :
  1. Concentration of levofloxacin and active control in the aqueous humor [ Time Frame: Time of surgery ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 4 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00630019

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

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Responsible Party: Brian Schwam, MD, VISTAKON Pharmaceuticals Identifier: NCT00630019     History of Changes
Other Study ID Numbers: VPH0107
First Posted: March 6, 2008    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009
Keywords provided by Santen Inc.:
Aqueous humor penetration by anti-infectives
Additional relevant MeSH terms:
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Lens Diseases
Norgestimate, ethinyl estradiol drug combination
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective 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
Anti-Infective Agents, Urinary
Renal Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors