NSAID vs Steroid in Trabeculectomy Wound Management | NCT03751059

Studies
NSAID vs Steroid in Trabeculectomy Wound Management

NCT03751059

Sponsor

Cindy Hutnik

Status

Unknown status

Last Update Posted

Oct 19, 2020Actual

Enrollment

150Estimated

Phase

Phase 4

Conditions

Glaucoma

Interventions

Bromfenac 0.07% Oph Susp
Dexamethasone

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2020Estimated

Primary Completion Date

Sep 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Nov 16, 2018

First Submission Date that Met QC Criteria

Nov 20, 2018

First Posted Date

Nov 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2020

Last Update Posted Date

Oct 19, 2020Actual

Name	Class
Glaucoma Research Society of Canada	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NSAID	Active Comparator	Bromfenac 0.07% Oph Susp: used from one week post-op to three months post-op	Drug: Bromfenac 0.07% Oph Susp
Steroid	Active Comparator	Dexamethasone: used from one week post-op to three months post-op	Drug: Dexamethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bromfenac 0.07% Oph Susp	Drug	Bromfenac 0.07% Oph Susp to be used post-operatively (week 1 to month 3) by one treatment group.	NSAID

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Study Coordinator	Contact	519.646.6100	66272	rboyd24@uwo.ca

Overall Officials

Name	Affiliation	Role
Cindy Hutnik, MD	Ivey Eye Institute	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C053083	bromfenac
D003907	Dexamethasone

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided