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

Primary Purpose

Cataract

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ISV-303
Bromday™
Sponsored by
Sun Pharmaceutical Industries Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring bromfenac concentrations, ISV-303, Bromday

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ISV-303

    Bromday™

    Arm Description

    Outcomes

    Primary Outcome Measures

    Mean Aqueous Humor Bromfenac Concentration

    Secondary Outcome Measures

    Full Information

    First Posted
    June 29, 2011
    Last Updated
    November 18, 2021
    Sponsor
    Sun Pharmaceutical Industries Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01387464
    Brief Title
    Aqueous Humor Concentration of InSite Vision (ISV) 303 (Bromfenac in DuraSite) to Bromday Once Daily (QD) Prior to Cataract Surgery
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2011 (undefined)
    Primary Completion Date
    August 2011 (Actual)
    Study Completion Date
    August 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sun Pharmaceutical Industries Limited

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract
    Keywords
    bromfenac concentrations, ISV-303, Bromday

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ISV-303
    Arm Type
    Experimental
    Arm Title
    Bromday™
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    ISV-303
    Intervention Description
    0.075% bromfenac in DuraSite dosed QD
    Intervention Type
    Drug
    Intervention Name(s)
    Bromday™
    Intervention Description
    0.09% bromfenac dosed QD
    Primary Outcome Measure Information:
    Title
    Mean Aqueous Humor Bromfenac Concentration
    Time Frame
    Approximately 3 hours post last dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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