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NSAID vs Steroid in Trabeculectomy Wound Management

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bromfenac 0.07% Oph Susp
Dexamethasone
Sponsored by
Cindy Hutnik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

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

Inclusion Criteria:

  • Adult patients over the age of 18 years
  • Uncontrolled open angle glaucoma
  • Scheduled to undergo stand-alone trabeculectomy
  • No previous incisional glaucoma surgery
  • No ocular surgery of any kind in prior 6 months

Exclusion Criteria:

  • steroids and/or NSAIDs contraindicated
  • poor corneal epithelial health

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    NSAID

    Steroid

    Arm Description

    Bromfenac 0.07% Oph Susp: used from one week post-op to three months post-op

    Dexamethasone: used from one week post-op to three months post-op

    Outcomes

    Primary Outcome Measures

    Target IOP
    the proportion of patients achieving a target IOP range (≤21, ≤18, ≤15 or ≤12 mmHg) at 12 months post-operatively

    Secondary Outcome Measures

    Full Information

    First Posted
    November 16, 2018
    Last Updated
    October 15, 2020
    Sponsor
    Cindy Hutnik
    Collaborators
    Glaucoma Research Society of Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03751059
    Brief Title
    NSAID vs Steroid in Trabeculectomy Wound Management
    Official Title
    An Investigator-Initiated Multicenter Prospective Clinical Trial to Examine the Efficacy of Peri-operative NSAID vs Steroid Treatment in Trabeculectomy Wound Management
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2020 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Cindy Hutnik
    Collaborators
    Glaucoma Research Society of Canada

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study will examine the efficacy of steroid vs NSAID treatment in relation to trabeculectomy wound management. Eligible study participants will be randomized to receive either steroid or NSAID topical treatment one week post-trabeculectomy. Each group will dose with their assigned study treatment until three months post-trabeculectomy. Study participants will be followed for twelve months post-trabeculectomy.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NSAID
    Arm Type
    Active Comparator
    Arm Description
    Bromfenac 0.07% Oph Susp: used from one week post-op to three months post-op
    Arm Title
    Steroid
    Arm Type
    Active Comparator
    Arm Description
    Dexamethasone: used from one week post-op to three months post-op
    Intervention Type
    Drug
    Intervention Name(s)
    Bromfenac 0.07% Oph Susp
    Other Intervention Name(s)
    Bromfenac
    Intervention Description
    Bromfenac 0.07% Oph Susp to be used post-operatively (week 1 to month 3) by one treatment group.
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Intervention Description
    Topical dexamethasone to be used by all study participants for one week pre-trabeculectomy and by all study participants for one week post-trabeculectomy. At one week post-op, one of the treatment groups will continue to dose with dexamethasone.
    Primary Outcome Measure Information:
    Title
    Target IOP
    Description
    the proportion of patients achieving a target IOP range (≤21, ≤18, ≤15 or ≤12 mmHg) at 12 months post-operatively
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients over the age of 18 years Uncontrolled open angle glaucoma Scheduled to undergo stand-alone trabeculectomy No previous incisional glaucoma surgery No ocular surgery of any kind in prior 6 months Exclusion Criteria: steroids and/or NSAIDs contraindicated poor corneal epithelial health
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Study Coordinator
    Phone
    519.646.6100
    Ext
    66272
    Email
    rboyd24@uwo.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cindy Hutnik, MD
    Organizational Affiliation
    Ivey Eye Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    NSAID vs Steroid in Trabeculectomy Wound Management

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