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NSAID vs Steroid in Trabeculectomy Wound Management

Sponsor
Cindy Hutnik (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03751059
Collaborator
Glaucoma Research Society of Canada (Other)
150
Enrollment
2
Arms
13
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Investigator-Initiated Multicenter Prospective Clinical Trial to Examine the Efficacy of Peri-operative NSAID vs Steroid Treatment in Trabeculectomy Wound Management
Anticipated Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: NSAID

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

Drug: Bromfenac 0.07% Oph Susp
Bromfenac 0.07% Oph Susp to be used post-operatively (week 1 to month 3) by one treatment group.
Other Names:
  • Bromfenac

    		•
    Active Comparator: Steroid

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

    Drug: Dexamethasone
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Target IOP [12 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cindy Hutnik
    • Glaucoma Research Society of Canada

    Investigators

    • Principal Investigator: Cindy Hutnik, MD, Ivey Eye Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cindy Hutnik, Principal Investigator, Ivey Eye Institute
    ClinicalTrials.gov Identifier:
    NCT03751059
    Other Study ID Numbers:
    • TWM
    First Posted:
    Nov 23, 2018
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Oct 1, 2020
    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
    Additional relevant MeSH terms:
    Glaucoma
    Dexamethasone
    Bromfenac

    Study Results

    No Results Posted as of Oct 19, 2020