View Clinical Trial (Medical Research Study)
Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification
| City: |
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Wilkes-Barre |
| State: |
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Pennsylvania |
| Zip Code: |
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18702 |
| Conditions: |
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Cataracts |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01296191 |
| Primary Contact: |
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Principal Investigator
Frank A. Bucci, Jr., MD
Bucci Laser Vision Institute
Ruth Evans, C.O.T.
Phone: 570-825-5949
Email: Ruth@buccivision.com
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| Backup Contact: |
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Email: Barb@buccivision.com
Barbara Michalek
Phone: 570-825-5949
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| Location Contact: |
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Wilkes-Barre, Pennsylvania 18702
United States
Ruth Evans
Phone: 570-825-5949
Email: Ruth@buccivision.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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