Status:
COMPLETED
Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects
Lead Sponsor:
Sun Pharmaceutical Industries Limited
Conditions:
Ocular Inflammation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the ocular safety, tolerability and efficacy of topical administration of ISV-303 compared with Durasite Vehicle.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT01808547
Start Date
May 1 2013
End Date
November 1 2013
Last Update
November 19 2021
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