Aqueous Humor Concentration of InSite Vision (ISV) 303 (Bromfenac in DuraSite) to Bromday Once Daily (QD) Prior to Cataract Surgery

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to routine cataract surgery.

Official Title
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A Double-Masked Clinical Study To Determine The Aqueous Humor Concentration Of Bromfenac Sodium In Subjects Administered Multiple Topical Ocular Doses Of ISV-303 Or Bromday™ Once Daily (QD) Prior To Cataract Surgery

Conditions
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Cataract

Intervention / Treatment
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* Drug: ISV-303
* Drug: Bromday™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects age 18 or older scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation If a female is of childbearing potential, the subject must agree to and submit a urine sample for pregnancy testing at Visit 1 prior to enrollment and at the end of the study, and 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 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) Exclusion Criteria: Use of any drug containing bromfenac within 2 weeks prior to surgery Contact lens wear during the dosing period Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the investigational medicinal product (IMP) or any of the procedural medications Any serious complications with or macroscopic damage to the corneal epithelium Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test Currently suffer from alcohol and/or drug abuse Prior participation in this study protocol 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ISV-303<br> | Drug: ISV-303<br>* 0.075% bromfenac in DuraSite dosed QD<br>|
| Active Comparator: Bromday™<br> | Drug: Bromday™<br>* 0.09% bromfenac dosed QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Aqueous Humor Bromfenac Concentration |  | Approximately 3 hours post last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bromfenac concentrations, ISV-303, Bromday