NSAID vs Steroid in Trabeculectomy Wound Management

October 15, 2020 updated by: Cindy Hutnik

An Investigator-Initiated Multicenter Prospective Clinical Trial to Examine the Efficacy of Peri-operative NSAID vs Steroid Treatment in Trabeculectomy Wound Management

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Study Coordinator
  • Phone Number: 66272 519.646.6100
  • Email: rboyd24@uwo.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cindy Hutnik

Collaborators

Glaucoma Research Society of Canada

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2020

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

November 16, 2018

First Submitted That Met QC Criteria

November 20, 2018

First Posted (ACTUAL)

November 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TWM

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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