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Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification

This study is currently recruiting participants.
Verified July 2011 by Bucci Laser Vision Institute
Sponsor:
Information provided by:
Bucci Laser Vision Institute
ClinicalTrials.gov Identifier:
NCT01296191
First received: February 14, 2011
Last updated: July 11, 2011
Last verified: July 2011
History of Changes
  Purpose

The purpose of this study is to compare drug concentrations in aqueous humor following ocular instillation of Besivance and VIGAMOX in subjects undergoing cataract surgery.


Condition Intervention Phase
Cataracts
 Drug: Moxifloxacin
Drug: besifloxacin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Bucci Laser Vision Institute:

Primary Outcome Measures:
  • Drug concentration levels and pharmacokinetics in aqueous humor samples. [ Time Frame: Measured after 3 days of drug instillation ] [ Designated as safety issue: No ]
    Concentration of Besivance and VIGAMOX in the aqueous humor will be determined by an independent laboratory using standardized high-pressure liquid chromatography and mass spectrometry assays. Pharmacokinetic parameters determined from the aqueous humor concentration will minimally include the area under the curve and the maximum concentration.


Estimated Enrollment: 120
Study Start Date: May 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: VIGAMOX
Subjects undergoing cataract surgery, randomized to the VIGAMOX group
 Drug: Moxifloxacin
One drop 4 times daily for 3 days and one drop the day of sample collection
Active Comparator: Besivance
Subjects scheduled for cataract surgery, randomized to the Besivance group
 Drug: besifloxacin
One drop 4 times daily for 3 days and one drop on day of sample collection

Detailed Description:

The objective of this study is to compare drug concentrations in aqueous humor following ocular instillation of Besivance or VIGAMOX in subjects undergoing cataract surgery. The hypothesis of the study is that the aggregate aqueous absorption of Besivance over a six hour period is greater than VIGAMOX because of unique properties of Besivance which promote increased contact time of this antibiotic with the ocular surface.

Subjects with scheduled cataract surgery will be screened during their pre-operative visit. Eligible subjects will be randomized to treatment with Besivance or VIGAMOX. Subjects will self-administer 1 drop of study drug into the operative eye 4 times a day for 3 days prior to surgery.Subjects will have one final drop of study medication on the day of surgery.Immediately prior to beginning the cataract surgery, a sample of aqueous humor will be collected by paracentesis.Concentration of Besivance and VIGAMOX in the aqueous humor will be determined by an independent laboratory using standardized high pressure liquid chromatography and mass spectrometry assays. Pharmacokinetic parameters determined from the aqueous humor concentration-time data will minimally include the area under the curve and the maximum concentration.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Man or woman 18 years of age or older.
  • Physically capable of instilling eye drop or have an appropriate person available to assist in administration of eye drops 4 times a day.
  • Scheduled for phacoemulsification with intraocular lens (IOL) implantation for the treatment of cataract.
  • Meet the American Society of Anesthesiology (ASA) physical status I, II, or III and be medically cleared for surgery.
  • Willing to adhere to the prohibitions and restrictions specified in this protocol.
  • Subjects 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 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.
  • Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection.
  • History of any significant illness that could be expected to interfere with the study parameters. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.

  • Use of disallowed therapies (systemic or topical):

    • Fluoroquinolone anti-infective agents (systemic or topical) within 1 week of Visit 1 or anytime after Visit 1 for the duration of the study.
  • Use of contact lenses for one week prior to the study and for the duration of the study.
  • Received an experimental drug or used an experimental medical device within 10 days before the planned start of treatment.
  • Breast-feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296191

Contacts
Contact: Ruth Evans, C.O.T. 570-825-5949 Ruth@buccivision.com
Contact: Barbara Michalek 570-825-5949 Barb@buccivision.com

Locations
United States, Pennsylvania
Bucci Laser Vision Institute Recruiting
Wilkes-Barre, Pennsylvania, United States, 18702
Contact: Ruth Evans     570-825-5949     Ruth@buccivision.com    
Contact: Barbara Michalek     570-825-5949     Barb@buccivision.com    
Sponsors and Collaborators
Bucci Laser Vision Institute
Investigators
Principal Investigator: Frank A. Bucci, Jr., MD Bucci Laser Vision Institute
  More Information

No publications provided

Responsible Party: Frank A. Bucci, Jr., MD, Bucci Laser Vision Institute
ClinicalTrials.gov Identifier: NCT01296191     History of Changes
Other Study ID Numbers: 2011-BV-A
Study First Received: February 14, 2011
Last Updated: July 11, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013