GlaucomaPhase 4NCT00811564

An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects

A Phase 4 study testing fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution and latanoprost 0.005% in people with Glaucoma and Ocular Hypertension, run by Allergan at 1 site in United States.

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

A three-month evaluation comparing the safety and efficacy of a fixed combination of 0.2% brimonidine tartrate/0.5% timolol maleate with that of latanoprost 0.005%, a prostaglandin analogue in glaucoma or ocular hypertension subjects Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Ocular Hypertension
What is being tested?: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution and latanoprost 0.005%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 148 participants
Where: 1 siteUnited States
Study dates: Dec 2008to Jan 2010
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

Be at least 18 years of age;
Give written informed consent;
Be in good general health as determined by your doctor;
Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension;
If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills);
Understand the study instructions, and be able to follow the study instructions; and
Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits.

Who cannot join

Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation;
Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Slingerlands, New York

Other trials in United States

About this study

Conditions: Glaucoma, Ocular Hypertension
Being tested: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution, latanoprost 0.005%
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.

fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solutionDrug
Also called Combigan™
1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day
latanoprost 0.005%Drug
Also called Xalatan™
1 drop of study medication taken once daily

Study groups in NCT00811564
Study group	Role	What they receive
1	Active comparator	Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution Receives: Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution
2	Active comparator	Latanoprost 0.005% ophthalmic solution Receives: Drug: latanoprost 0.005%

What is being measured

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

Intraocular Pressure (IOP) at Week 12
Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye.
Measured: Week 12

Timeline

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

Dec 2008Jan 2010

First posted19 Dec 2008 (estimated)
Study startDec 2008
Primary completionJan 2010
Study completionJan 2010

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 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: Single blind
Who is masked: Investigator
Enrolment: 148 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00811564
Sponsor's protocol ID: GMA-COM-08-008
Status last verified: Aug 2011
First submitted: 17 Dec 2008
Last updated: 21 Sep 2011
Results posted: Yes, on ClinicalTrials.gov

Publications

Katz LJ, Rauchman SH, Cottingham AJ Jr, Simmons ST, Williams JM, Schiffman RM, Hollander DA. Fixed-combination brimonidine-timolol versus latanoprost in glaucoma and ocular hypertension: a 12-week, randomized, comparison study. Curr Med Res Opin. 2012 May;28(5):781-8. doi: 10.1185/03007995.2012.681036. Epub 2012 Apr 25.
PubMed 22458918

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 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects
ClinicalTrials.gov ID: NCT00811564
Acronym / sponsor ID: GMA-COM-08-008
Conditions: Glaucoma, Ocular Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 148 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 19 Dec 2008 (estimated)
Results: Posted 21 Sep 2011

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: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solutionFixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
2	Active comparator	Drug: latanoprost 0.005%Latanoprost 0.005% ophthalmic solution

Who may qualify

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

Key inclusion criteria (7 listed)

Be at least 18 years of age;
Give written informed consent;
Be in good general health as determined by your doctor;
Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension;
If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills);

Key exclusion criteria (3 listed)

Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation;
Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit

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
fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solutionAlso: Combigan™1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day	Drug	1
latanoprost 0.005%Also: Xalatan™1 drop of study medication taken once daily	Drug	2

Primary outcome

Intraocular Pressure (IOP) at Week 12
Time frame: Week 12
Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye.

Results and safety

Results posted to the registry on 21 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate	73	64
Latanoprost 0.005% Ophthalmic Solution	75	73

Primary outcome: Intraocular Pressure (IOP) at Week 12

Time frame: Week 12. Mean (Standard Deviation). Unit: Millimeters of mercury (mm Hg)

Measure	Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate n = 73	Latanoprost 0.005% Ophthalmic Solution n = 75
Value	17.75 (2.878)	17.90 (3.943)

Population analysed: Intent-to-treat, which included all patients who started the study (randomized).

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate	0 of 73 (0%)	8 of 73 (11%)	Not reported
Latanoprost 0.005% Ophthalmic Solution	1 of 75 (1.3%)	0 of 75 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22458918Katz LJ, Rauchman SH, Cottingham AJ Jr, Simmons ST, Williams JM, Schiffman RM, Hollander DA. Fixed-combination brimonidine-timolol versus latanoprost in glaucoma and ocular hypertension: a 12-week, randomized, comparison study. Curr Med Res Opin. 2012 May;28(5):781-8. doi: 10.1185/03007995.2012.681036. Epub 2012 Apr 25.

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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 7 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 21 Sep 2011. 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 United States. 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 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 21 Sep 2011). 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?

Intraocular Pressure (IOP) at Week 12 (time frame: 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 NCT00811564, 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 21 Sep 2011.