GlaucomaPhase 4NCT01415401

Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada

A Phase 4 study testing Brinzolamide 1% / timolol 0.5% maleate fixed combination in people with Glaucoma and Ocular Hypertension, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior brimonidine 0.2%/timolol 0.5% fixed combination (COMBIGAN®) therapy in patients with open-angle glaucoma or ocular hypertension and uncontrolled intraocular pressure (IOP). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Ocular Hypertension, Open-angle Glaucoma
What is being tested?: Brinzolamide 1% / timolol 0.5% maleate fixed combination
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: No sites listed yet
Study dates: Sep 2011to Jun 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Willing to sign an Informed Consent form.
Clinical diagnosis of ocular hypertension, exfoliative open-angle or pigment dispersion glaucoma in at least one eye (study eye).
Be on a stable IOP lowering regimen within 30 days of Screening Visit.
IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
Willing to discontinue the use of COMBIGAN® prior to receiving the study drug at Visit 1.
IOP of between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.

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Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 logMAR) or better in each eye.
Willing to follow instructions and able to attend required study visits.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Known history of hypersensitivity to any component of the preparations used in this study.
Presence of primary or secondary glaucoma not listed in inclusion criterion #2.
History of ocular herpes simplex.
Abnormality preventing reliable applanation tonometry.
Corneal dystrophies.
Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.

Show all 12Show fewer

Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months prior to the Screening Visit.
Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
Progressive retinal or optic nerve disease from any cause.
Women of childbearing potential not using reliable means of birth control for at least 1 month prior to the Screening/Baseline Visit.
Pregnant or lactating.
Other protocol-defined exclusion criteria may apply.

About this study

Official title: Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Canada

Conditions: Glaucoma, Ocular Hypertension, Open-angle Glaucoma
Being tested: Brinzolamide 1% / timolol 0.5% maleate fixed combination
Keywords: Glaucoma, Ocular hypertension, Intraocular pressure (IOP), Open angle glaucoma, Pigment dispersion glaucoma, Pigmentary
Medical subject headings: Glaucoma, Ocular Hypertension, Glaucoma, Open-Angle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brinzolamide 1% / timolol 0.5% maleate fixed combinationDrug
Also called AZARGA®

Study groups in NCT01415401
Study group	Role	What they receive
AZARGA	Experimental	Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM) Receives: Drug: Brinzolamide 1% / timolol 0.5% maleate fixed combination

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline)
IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
Measured: Baseline, Week 8

Secondary outcomes (1)

Percentage of Subjects Who Reach Target IOP (≤ 18 mmHg)
IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Jun 2013

First posted12 Aug 2011 (estimated)
Study startSep 2011
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GlaucomaStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01415401
Sponsor's protocol ID: RDG-11-199
Status last verified: May 2014
First submitted: 10 Aug 2011
Last updated: 1 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Canada
ClinicalTrials.gov ID: NCT01415401
Acronym / sponsor ID: RDG-11-199
Conditions: Glaucoma, Ocular Hypertension, Open-angle Glaucoma
Keywords: Glaucoma, Ocular hypertension, Intraocular pressure (IOP), Open angle glaucoma, Pigment dispersion glaucoma, Pigmentary
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 12 Aug 2011 (estimated)
Results: Posted 1 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AZARGA	Experimental	Drug: Brinzolamide 1% / timolol 0.5% maleate fixed combinationBrinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Willing to sign an Informed Consent form.
Clinical diagnosis of ocular hypertension, exfoliative open-angle or pigment dispersion glaucoma in at least one eye (study eye).
Be on a stable IOP lowering regimen within 30 days of Screening Visit.
IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
Willing to discontinue the use of COMBIGAN® prior to receiving the study drug at Visit 1.

Key exclusion criteria (12 listed)

Known history of hypersensitivity to any component of the preparations used in this study.
Presence of primary or secondary glaucoma not listed in inclusion criterion #2.
History of ocular herpes simplex.
Abnormality preventing reliable applanation tonometry.
Corneal dystrophies.

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
Brinzolamide 1% / timolol 0.5% maleate fixed combinationAlso: AZARGA®	Drug	AZARGA

Primary outcome

Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline)
Time frame: Baseline, Week 8
IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.

1 secondary outcome

Percentage of Subjects Who Reach Target IOP (≤ 18 mmHg)
Time frame: Week 8

Results and safety

Results posted to the registry on 1 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZARGA	54	47

Primary outcome: Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline)

Time frame: Baseline, Week 8. Mean (Standard Deviation). Unit: mmHg

Measure	AZARGA n = 54
Baseline	22.24 (3.150)
Change from baseline at Week 8	-2.24 (3.928)

Population analysed: This analysis population includes all subjects who received study medication and had at least one on-therapy study visit. Last observation carried forward (LOCF) was used.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study (1 year, 9 months). This analysis group includes all subjects who received study medication.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZARGA	1 of 54 (1.9%)	0 of 54 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Danyel C. Carr, MS, CCRA study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Brinzolamide 1% / timolol 0.5% maleate fixed combination in people with Glaucoma and Ocular Hypertension, run by Alcon Research.

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 9 inclusion and 12 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: finished, as of the sponsor's last update on 1 Jul 2014. 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?

Yes. Results are posted in the registry (first posted 1 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline) (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01415401.

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 1 Jul 2014.