Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Bucci Laser Vision Institute.
Recruitment status was  Recruiting
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

February 14, 2011
July 11, 2011
May 2011
November 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01296191 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification
Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Cataracts
  • Drug: Moxifloxacin
    One drop 4 times daily for 3 days and one drop the day of sample collection
  • Drug: besifloxacin
    One drop 4 times daily for 3 days and one drop on day of sample collection
  • Active Comparator: VIGAMOX
    Subjects undergoing cataract surgery, randomized to the VIGAMOX group
    Intervention: Drug: Moxifloxacin
  • Active Comparator: Besivance
    Subjects scheduled for cataract surgery, randomized to the Besivance group
    Intervention: Drug: besifloxacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Ruth Evans, C.O.T. 570-825-5949 Ruth@buccivision.com
Contact: Barbara Michalek 570-825-5949 Barb@buccivision.com
United States
 
NCT01296191
2011-BV-A
No
Frank A. Bucci, Jr., MD, Bucci Laser Vision Institute
Bucci Laser Vision Institute
Not Provided
Principal Investigator: Frank A. Bucci, Jr., MD Bucci Laser Vision Institute
Bucci Laser Vision Institute
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP