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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:11/23/2013
Start Date:April 2013
End Date:December 2013
Contact:Judith Hutcheson
Email:jhutcheson@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 medications for the duration of the study

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

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

- Additional inclusion criteria also apply

Exclusion Criteria:

- Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the
IMP 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 (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 inclusion criteria also apply
We found this trial at
15
sites
Memphis, Tennessee 38119
503
mi
from 43215
Memphis, TN
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Chandler, Arizona
1654
mi
from 43215
Chandler, AZ
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High Point, North Carolina 27262
321
mi
from 43215
High Point, NC
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Kansas City, Missouri 64111
619
mi
from 43215
Kansas City, MO
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Newport Beach, California
1967
mi
from 43215
Newport Beach, CA
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1662
mi
from 43215
Phoenix, AZ
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Rancho Cordova, California 95670
2033
mi
from 43215
Rancho Cordova, CA
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San Antonio, Texas 78209
1134
mi
from 43215
San Antonio, TX
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San Diego, California
1951
mi
from 43215
San Diego, CA
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St. Joseph, Michigan 49085
232
mi
from 43215
St. Joseph, MI
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St. Louis, Missouri 63148
397
mi
from 43215
St. Louis, MO
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St. Louis, Missouri
394
mi
from 43215
St. Louis, MO
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963
mi
from 43215
Tamarac, FL
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1205
mi
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Uvalde, TX
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Winston-Salem, North Carolina 27101
307
mi
from 43215
Winston-Salem, NC
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