Comparison Study of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:July 2012
End Date:January 2013
Contact:Elizabeth Padilla
Email:EPadilla@insite.com

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A Randomized Double-Masked Study to Compare the Ocular Safety, Tolerability, and Efficacy of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects


The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of
topical administration of ISV-303 compared with DuraSite Vehicle.


Inclusion Criteria:

- Male or female subjects age 18 or older scheduled for unilateral cataract surgery
with posterior chamber intraocular lens implantation

- If a female is of childbearing potential, the subject must agree to and submit a
negative pregnancy test before any protocol-specific procedures are conducted. The
subject must use effective contraception for the duration of the study. Post
menopausal is defined as having no menses for at least 12 consecutive months

- Signature of the subject on the Informed Consent Form

- Willing to avoid disallowed medication for the duration of the study.

- Willing and able to follow all instructions and attend all study visits

- Able to self-administer study drug (or have a caregiver available to instill all
doses of study drug)

- Additional inclusion criteria also apply

Exclusion Criteria:

- Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the
study medications or any of the procedural medications

- Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a
positive pregnancy test

- Currently suffer from alcohol and/or drug abuse

- Prior participation in this study protocol

- Prior (within 30 days of beginning study treatment) or anticipated concurrent use of
an investigational drug or device

- A condition or a situation, which in the investigator's opinion may put the subject
at increased risk, confound study data, or interfere significantly with the subject's
study participation

- Additional exclusion criteria also apply
We found this trial at
15
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Kansas City, Missouri 64133
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Austin, Texas 78731
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Brooksville, Florida 34613
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Charlotte, North Carolina 28210
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Cincinnati, OH
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Gretna, Louisiana
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High Point, North Carolina 27262
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Kingston, Pennsylvania 18704
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Kingston, PA
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Mission Hills, California
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Mission Hills, CA
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Petaluma, California 94954
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Phoenix, AZ
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St. Joseph, Michigan 49085
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St. Louis, Missouri
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Tampa, FL
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Wantagh, New York 11793
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Wantagh, NY
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