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Comparison Study of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects (ISV-303)

Primary Purpose

Ocular Inflammation

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ISV-303
DuraSite Vehicle
Sponsored by
Sun Pharmaceutical Industries Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Inflammation

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 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    ISV-303

    DuraSite Vehicle

    Arm Description

    0.075% bromfenac in DuraSite vehicle dosed BID

    DuraSite Vehicle dosed BID

    Outcomes

    Primary Outcome Measures

    Ocular Inflammation
    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 Outcome Measures

    Full Information

    First Posted
    April 10, 2012
    Last Updated
    November 18, 2021
    Sponsor
    Sun Pharmaceutical Industries Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01576952
    Brief Title
    Comparison Study of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects
    Acronym
    ISV-303
    Official Title
    A Randomized Double-Masked Study to Compare the Ocular Safety, Tolerability, and Efficacy of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2012 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    January 2013 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ocular Inflammation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    268 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ISV-303
    Arm Type
    Experimental
    Arm Description
    0.075% bromfenac in DuraSite vehicle dosed BID
    Arm Title
    DuraSite Vehicle
    Arm Type
    Placebo Comparator
    Arm Description
    DuraSite Vehicle dosed BID
    Intervention Type
    Drug
    Intervention Name(s)
    ISV-303
    Intervention Description
    Bromfenac in DuraSite
    Intervention Type
    Other
    Intervention Name(s)
    DuraSite Vehicle
    Intervention Description
    DuraSite Vehicle
    Primary Outcome Measure Information:
    Title
    Ocular Inflammation
    Description
    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.
    Time Frame
    15 days

    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 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

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison Study of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects

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