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

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bucci Laser Vision Institute; Frank A. Bucci, Jr., M.D.
• Treatments: 7-(3-aminohexahydro-1H-azepin-1-yl)-8-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid; Besifloxacin; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

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