Comparison Study of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects
Status and phase
Completed
Phase 3
Conditions
Ocular Inflammation
Treatments
Other: DuraSite Vehicle
Drug: ISV-303
Details and patient eligibility
About
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of topical administration of ISV-303 compared with DuraSite Vehicle.
Enrollment
268 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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 (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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
268 participants in 2 patient groups, including a placebo group
ISV-303
Experimental group
Description:
0.075% bromfenac in DuraSite vehicle dosed BID
Treatment:
Drug: ISV-303
DuraSite Vehicle
Placebo Comparator group
Description:
DuraSite Vehicle dosed BID
Treatment:
Other: DuraSite Vehicle
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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