GlaucomaNCT01229462

Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

A study testing brimonidine tartrate/timolol fixed combination ophthalmic solution, brimonidine tartrate ophthalmic solution and timolol ophthalmic solution in people with Glaucoma and Ocular Hypertension, run by Allergan at 1 site in China.

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 brimonidine tartrate/timolol fixed combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Glaucoma, Ocular Hypertension
What is being tested?: brimonidine tartrate/timolol fixed combination ophthalmic solution, brimonidine tartrate ophthalmic solution and timolol ophthalmic solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 238 participants
Where: 1 siteChina
Study dates: Oct 2010to Sep 2011
Phase: Interventional
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Open-angle glaucoma or ocular hypertension in at least one eye that is not responsive to topical beta blockers
No anticipated wearing of contact lenses during study

Who cannot join

Active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
Any intraocular surgery or laser (eg, cataract surgery or Lasik) within 3 months
Required regular use of other ocular medications except for occasional use of artificial tears

Trial locations and contacts

1 site in 1 country.

China1 site

Study site
Guangzhou, Guangdong

Other trials in China

About this study

Conditions: Glaucoma, Ocular Hypertension
Being tested: brimonidine tartrate/timolol fixed combination ophthalmic solution, brimonidine tartrate ophthalmic solution, timolol ophthalmic solution, fixed combination vehicle
Medical subject headings: Glaucoma, Ocular Hypertension

What participants receive

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

brimonidine tartrate/timolol fixed combination ophthalmic solutionDrug
Also called Combigan®
One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.
brimonidine tartrate ophthalmic solutionDrug
Also called Alphagan®
One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.
timolol ophthalmic solutionDrug
One drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
fixed combination vehicleOther
Fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Study groups in NCT01229462
Study group	Role	What they receive
Combigan®	Other	One drop of brimonidine tartrate/timolol combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks. Receives: Drug: brimonidine tartrate/timolol fixed combination ophthalmic solution; Other: fixed combination vehicle
Alphagan® and Timolol Concurrent	Active comparator	One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks. Receives: Drug: brimonidine tartrate ophthalmic solution; Drug: 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 Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4
Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).
Measured: Baseline, Week 4

Timeline

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

Oct 2010Sep 2011

First posted27 Oct 2010 (estimated)
Study startOct 2010
Primary completionSep 2011
Study completionSep 2011

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.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 238 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01229462
Sponsor's protocol ID: 190342-035
Status last verified: Aug 2012
First submitted: 26 Oct 2010
Last updated: 14 Sep 2012
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?

See locations

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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT01229462
Acronym / sponsor ID: 190342-035
Conditions: Glaucoma, Ocular Hypertension
Study type: Interventional
Recruitment status: Completed
Enrolment: 238 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 27 Oct 2010 (estimated)
Results: Posted 14 Sep 2012

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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Combigan®	Other	Drug: brimonidine tartrate/timolol fixed combination ophthalmic solution, Other: fixed combination vehicleOne drop of brimonidine tartrate/timolol combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Alphagan® and Timolol Concurrent	Active comparator	Drug: brimonidine tartrate ophthalmic solution, Drug: timolol ophthalmic solutionOne drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Open-angle glaucoma or ocular hypertension in at least one eye that is not responsive to topical beta blockers
No anticipated wearing of contact lenses during study

Key exclusion criteria (3 listed)

Active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
Any intraocular surgery or laser (eg, cataract surgery or Lasik) within 3 months
Required regular use of other ocular medications except for occasional use of artificial tears

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
brimonidine tartrate/timolol fixed combination ophthalmic solutionAlso: Combigan®One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.	Drug	Combigan®
brimonidine tartrate ophthalmic solutionAlso: Alphagan®One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.	Drug	Alphagan® and Timolol Concurrent
timolol ophthalmic solutionOne drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.	Drug	Alphagan® and Timolol Concurrent
fixed combination vehicleFixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.	Other	Combigan®

Primary outcome

Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4
Time frame: Baseline, Week 4
Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).

Results and safety

Results posted to the registry on 14 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Combigan®	120	115
Alphagan® and Timolol Concurrent	118	109

Primary outcome: Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4

Time frame: Baseline, Week 4. Mean (Standard Deviation). Unit: mm Hg

Measure	Combigan® n = 120	Alphagan® and Timolol Concurrent n = 118
Baseline	25.07 (3.737)	24.53 (2.926)
Change from baseline at Week 4	-6.21 (3.550)	-5.70 (3.469)

Population analysed: Intent-to-treat population consisted of all randomized participants.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Combigan®	1 of 120 (0.8%)	0 of 120 (0%)	Not reported
Alphagan® and Timolol Concurrent	1 of 116 (0.9%)	0 of 116 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2012.
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.

Medical Director study director

Allergan

1 site in 1 country: 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 3 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 14 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2012). 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 Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4 (time frame: Baseline, Week 4). 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 NCT01229462.

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 14 Sep 2012.