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 |
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
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