Glaucoma, Open-AnglePhase 3NCT01241240

Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

A Phase 3 study testing bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy) and Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 2 sites in 2 countries.

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

This study will evaluate the safety and efficacy of Triple Combination Therapy compared with Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary 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, Open-Angle, Ocular Hypertension
What is being tested?: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy) and Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 192 participants
Where: 2 sitesin 2 countries
Study dates: Mar 2011to Sep 2013
Phase: Phase 3
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

Ocular hypertension or primary open-angle glaucoma in each eye
Requires treatment with IOP-lowering medication in both eyes

Who cannot join

Required chronic use of ocular medications during the study other than study medication
Use of any corticosteroids within 30 days
History of any prior eye surgery, except for uncomplicated eye surgery performed more than 6 months before the Screening visit
Anticipated wearing of contact lenses during the study

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Colombia1 site

Study site
Bogotá

Other trials in Colombia

Mexico1 site

Study site
Mexico City

Other trials in Mexico

About this study

Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Being tested: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy), Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

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

bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)Drug
One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solutionDrug
Also called COMBIGAN®
One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.

Study groups in NCT01241240
Study group	Role	What they receive
Triple Combination Therapy	Experimental	Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks. Receives: Drug: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)
Combigan®	Active comparator	Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks. Receives: Drug: Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution

What is being measured

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

Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12
IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at week 12. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 12

Secondary outcomes (2)

Change From Baseline in Mean Worse Eye IOP
IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each visit. A negative change from Baseline indicated improvement.
Measured: Baseline, Weeks 1, 2, 4 and 8
Mean Worse Eye IOP
IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each time-point.
Measured: Weeks 1, 2, 4, 8 and 12

Timeline

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

Mar 2011Sep 2013

First posted16 Nov 2010 (estimated)
Study startMar 2011
Primary completionSep 2013
Study completionSep 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Glaucoma, Open-AngleStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 192 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01241240
Sponsor's protocol ID: 192024-063
Status last verified: Sep 2014
First submitted: 12 Nov 2010
Last updated: 10 Sep 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hartleben C, Parra JC, Batoosingh A, Bernstein P, Goodkin M. A Masked, Randomized, Phase 3 Comparison of Triple Fixed-Combination Bimatoprost/Brimonidine/Timolol versus Fixed-Combination Brimonidine/Timolol for Lowering Intraocular Pressure. J Ophthalmol. 2017;2017:4586763. doi: 10.1155/2017/4586763. Epub 2017 Sep 19.
PubMed 29057117

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?

See locations

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)
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
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma

All Glaucoma, Open-Angle trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT01241240
Acronym / sponsor ID: 192024-063
Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 192 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 16 Nov 2010 (estimated)
Results: Posted 10 Sep 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Triple Combination Therapy	Experimental	Drug: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
Combigan®	Active comparator	Drug: Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solutionFixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.

Who may qualify

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

Key inclusion criteria (2 listed)

Ocular hypertension or primary open-angle glaucoma in each eye
Requires treatment with IOP-lowering medication in both eyes

Key exclusion criteria (4 listed)

Required chronic use of ocular medications during the study other than study medication
Use of any corticosteroids within 30 days
History of any prior eye surgery, except for uncomplicated eye surgery performed more than 6 months before the Screening visit
Anticipated wearing of contact lenses during the study

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
bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.	Drug	Triple Combination Therapy
Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solutionAlso: COMBIGAN®One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.	Drug	Combigan®

Primary outcome

Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12
Time frame: Baseline, Week 12
IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at week 12. A negative change from Baseline indicated improvement.

2 secondary outcomes

Change From Baseline in Mean Worse Eye IOP
Time frame: Baseline, Weeks 1, 2, 4 and 8
Mean Worse Eye IOP
Time frame: Weeks 1, 2, 4, 8 and 12

Results and safety

Results posted to the registry on 10 Sep 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
Triple Combination Therapy	94	86
Combigan®	98	89

Primary outcome: Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: mmHg

Measure	Triple Combination Therapy n = 93	Combigan® n = 97
Baseline (n=93,95)	24.62 (2.475)	25.12 (2.178)
Change from Baseline at Week 12 (n=93,94)	-10.03 (2.661)	-9.18 (2.566)

Population analysed: Participants from the modified Intent-to-treat (mITT) population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Triple Combination Therapy	3 of 93 (3.2%)	57 of 93 (61.3%)	Not reported
Combigan®	0 of 98 (0%)	25 of 98 (25.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29057117Hartleben C, Parra JC, Batoosingh A, Bernstein P, Goodkin M. A Masked, Randomized, Phase 3 Comparison of Triple Fixed-Combination Bimatoprost/Brimonidine/Timolol versus Fixed-Combination Brimonidine/Timolol for Lowering Intraocular Pressure. J Ophthalmol. 2017;2017:4586763. doi: 10.1155/2017/4586763. Epub 2017 Sep 19.

Related trials for Glaucoma, Open-Angle

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)
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
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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.

Medical Director study director

Allergan

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 4 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 10 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Colombia, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 10 Sep 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 From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12 (time frame: Baseline, Week 12). 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 NCT01241240, which also lists 1 linked publication.

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 10 Sep 2014.