GlaucomaPhase 4NCT03751059
NSAID vs Steroid in Trabeculectomy Wound Management
A Phase 4 study testing Bromfenac 0.07% Oph Susp and Dexamethasone in people with Glaucoma, run by Cindy Hutnik.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Bromfenac 0.07% Oph Susp and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- steroids and/or NSAIDs contraindicated
- poor corneal epithelial health
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Glaucoma
- Being tested
- Bromfenac 0.07% Oph Susp, Dexamethasone
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bromfenac 0.07% Oph SuspDrug
Also called Bromfenac
Bromfenac 0.07% Oph Susp to be used post-operatively (week 1 to month 3) by one treatment group.
DexamethasoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| NSAID | Active comparator | Bromfenac 0.07% Oph Susp: used from one week post-op to three months post-op Receives: Drug: Bromfenac 0.07% Oph Susp |
| Steroid | Active comparator | Dexamethasone: used from one week post-op to three months post-op Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target IOP
the proportion of patients achieving a target IOP range (≤21, ≤18, ≤15 or ≤12 mmHg) at 12 months post-operatively
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study startNov 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cindy Hutnik
- Sponsor type
- University, hospital or other
- Collaborators
- Glaucoma Research Society of Canada
- Responsible party
- Sponsor-investigator, Cindy Hutnik, Ivey Eye Institute
- Investigators
- Cindy Hutnik, MD, Principal investigator, Ivey Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751059
- Sponsor's protocol ID
- TWM
- Status last verified
- Oct 2020
- First submitted
- 16 Nov 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-Initiated Multicenter Prospective Clinical Trial to Examine the Efficacy of Peri-operative NSAID vs Steroid Treatment in Trabeculectomy Wound Management
- ClinicalTrials.gov ID
- NCT03751059
- Acronym / sponsor ID
- TWM
- Conditions
- Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cindy HutnikUniversity, hospital or other
- Collaborators
- Glaucoma Research Society of Canada
- Study start
- Nov 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSAID | Active comparator | Drug: Bromfenac 0.07% Oph SuspBromfenac 0.07% Oph Susp: used from one week post-op to three months post-op |
| Steroid | Active comparator | Drug: DexamethasoneDexamethasone: used from one week post-op to three months post-op |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- steroids and/or NSAIDs contraindicated
- poor corneal epithelial health
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bromfenac 0.07% Oph SuspAlso: BromfenacBromfenac 0.07% Oph Susp to be used post-operatively (week 1 to month 3) by one treatment group. | Drug | NSAID |
| DexamethasoneTopical 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. | Drug | Steroid |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
Related trials for Glaucoma
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy Hutnik, MD principal investigator
Ivey Eye Institute
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bromfenac 0.07% Oph Susp and Dexamethasone in people with Glaucoma, run by Cindy Hutnik.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (519.646.6100 ext. 66272, rboyd24@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target IOP (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.