NSAID vs Steroid in Trabeculectomy Wound Management

NCT ID: NCT03751059

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NSAID

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

Group Type ACTIVE_COMPARATOR

Bromfenac 0.07% Oph Susp

Intervention Type DRUG

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

Steroid

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

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

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.

Interventions

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Bromfenac 0.07% Oph Susp

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Bromfenac

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glaucoma Research Society of Canada

OTHER

Sponsor Role collaborator

Cindy Hutnik

OTHER

Sponsor Role lead

Responsible Party

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Cindy Hutnik

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Cindy Hutnik, MD

Role: PRINCIPAL_INVESTIGATOR

Ivey Eye Institute

Central Contacts

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Study Coordinator

Role: CONTACT

519.646.6100 ext. 66272

Other Identifiers

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TWM

Identifier Type: -

Identifier Source: org_study_id

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