NCT01808547CompletedPhase 3
A Randomized Double-Masked Study to Compare the Ocular Safety,Tolerability,and Efficacy of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 268
- Primary Endpoint
- Ocular Inflammation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ISV-303
Experimental
Intervention: ISV-303 (Drug)
Durasite Vehicle
Placebo Comparator
Intervention: DuraSite Vehicle (Other)
Outcomes
Primary Outcomes
Ocular Inflammation
Time Frame: 15 days
Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is \> 50 cells, and no rescue medications.
Secondary Outcomes
No secondary outcomes reported
Investigators
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