GlaucomaPhase 4NCT01518244

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

A Phase 4 study testing Brinzolamide/timolol maleate fixed combination in people with Glaucoma, run by Alcon Research.

Completed

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

Trial summary

The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in participants with open-angle glaucoma or ocular hypertension. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma
What is being tested?: Brinzolamide/timolol maleate fixed combination
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: No sites listed yet
Study dates: Dec 2011to Feb 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

Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
On a stable IOP (intra-ocular pressure) lowering regimen within 30 days of Screening Visit.
IOP considered safe in both eyes in order to assure clinical stability of vision and optic nerve throughout the study period.
Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
IOP between 19 and 35 mmHG in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Presence of other primary or secondary glaucoma.
History of ocular herpes simplex.
Any 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.
Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to Screening Visit.

Show all 11Show fewer

Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the opinion of the investigator.
Progressive retinal or optic nerve disease from any cause.
Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
Pregnant or lactating.
Other protocol-defined exclusion criteria may apply.

About this study

The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in participants with open-angle glaucoma or ocular hypertension.

Conditions: Glaucoma
Being tested: Brinzolamide/timolol maleate fixed combination
Keywords: Primary open angle-glaucoma, Ocular hypertension, Pigment dispersion glaucoma
Medical subject headings: Glaucoma, Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

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

Brinzolamide/timolol maleate fixed combinationDrug
Also called AZARGA®

Study groups in NCT01518244
Study group	Role	What they receive
AZARGA®	Experimental	Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks Receives: Drug: Brinzolamide/timolol maleate fixed combination

What is being measured

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

Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. 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) at Week 8
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. 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.

Dec 2011Feb 2013

First posted25 Jan 2012 (estimated)
Study startDec 2011
Primary completionFeb 2013
Study completionFeb 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: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01518244
Sponsor's protocol ID: RDG-11-198
Status last verified: Feb 2014
First submitted: 23 Jan 2012
Last updated: 7 Aug 2015
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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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2015. 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 Brimonidine 0.2%/Timolol 0.5% Fixed Combination Therapy (COMBIGAN®) in Latin America
ClinicalTrials.gov ID: NCT01518244
Acronym / sponsor ID: RDG-11-198
Conditions: Glaucoma
Keywords: Primary open angle-glaucoma, Ocular hypertension, Pigment dispersion glaucoma
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 25 Jan 2012 (estimated)
Results: Posted 4 Apr 2014

Clinical summary

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

The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in participants with open-angle glaucoma or ocular hypertension.

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/timolol maleate fixed combinationBrinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks

Who may qualify

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

Key inclusion criteria (6 listed)

Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
On a stable IOP (intra-ocular pressure) lowering regimen within 30 days of Screening Visit.
IOP considered safe in both eyes in order to assure clinical stability of vision and optic nerve throughout the study period.
Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
IOP between 19 and 35 mmHG in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.

Key exclusion criteria (11 listed)

Presence of other primary or secondary glaucoma.
History of ocular herpes simplex.
Any 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.

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/timolol maleate fixed combinationAlso: AZARGA®	Drug	AZARGA®

Primary outcome

Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8
Time frame: Baseline, Week 8
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. 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) at Week 8
Time frame: Week 8

Results and safety

Results posted to the registry on 4 Apr 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®	50	47

Primary outcome: Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8

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

Measure	AZARGA® n = 49
Value	-3.60 (3.01)

Population analysed: The analysis population includes all participants who received AZARGA® and with at least 1 on-therapy study visit (V2 or V3).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study (December 2011-February 2013). An AE was defined as any untoward medical occurrence in a subject administered the test product, regardless of causal relationship with such product.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZARGA®	0 of 50 (0%)	4 of 50 (8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
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Recruiting
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Recruiting
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RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)

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.

Doug Hubatsch study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Brinzolamide/timolol maleate fixed combination in people with Glaucoma, 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 6 inclusion and 11 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 7 Aug 2015. 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 4 Apr 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?

Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8 (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 NCT01518244.

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 7 Aug 2015.