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

Information source: Bucci Laser Vision Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cataracts

Intervention: Moxifloxacin (Drug); besifloxacin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Bucci Laser Vision Institute

Official(s) and/or principal investigator(s):
Frank A. Bucci, Jr., MD, Principal Investigator, Affiliation: Bucci Laser Vision Institute

Overall contact:
Ruth Evans, C.O.T., Phone: 570-825-5949, Email: Ruth@buccivision.com

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Primary outcome: Drug concentration levels and pharmacokinetics in aqueous humor samples.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Ruth Evans, C.O.T., Phone: 570-825-5949, Email: Ruth@buccivision.com

Bucci Laser Vision Institute, Wilkes-Barre, Pennsylvania 18702, United States; Recruiting
Ruth Evans, Phone: 570-825-5949, Email: Ruth@buccivision.com
Barbara Michalek, Phone: 570-825-5949, Email: Barb@buccivision.com
Additional Information

Starting date: May 2011
Last updated: July 11, 2011

Page last updated: August 23, 2015

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