Glaucoma, Angle-ClosurePhase 4NCT01151904

Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients

A Phase 4 study testing brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution and latanoprost in people with Glaucoma, Angle-Closure, run by Allergan at 1 site in Thailand.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study will evaluate the safety and efficacy of patients switched from latanoprost monotherapy to a combination therapy of latanoprost with COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) for chronic angle closure glaucoma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Angle-Closure
What is being tested?: brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution and latanoprost
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteThailand
Study dates: Nov 2009to Feb 2012
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

Patient has been administering latanoprost eye drops in affected eye(s) for at least 12 weeks prior to study
Patient must have at least partially responded to latanoprost and requiring further IOP lowering eye drops
Diagnosis of chronic angle-closure glaucoma
Patients using COMBIGAN® in the past must not have been discontinued due to adverse events or lack of efficacy.

Who cannot join

Known allergy or hypersensitivity to COMBIGAN®
Corneal abnormalities that would preclude accurate IOP readings
Any other active ocular disease other than glaucoma or ocular hypertension
Ocular surgery within the past 3 months.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Study site
Bangkok

Other trials in Thailand

About this study

Conditions: Glaucoma, Angle-Closure
Being tested: brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution, latanoprost
Medical subject headings: Glaucoma, Angle-Closure

What participants receive

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

brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solutionDrug
Also called COMBIGAN®
COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) administered as one drop in the morning and one drop in the evening in affected eye(s) for 12 weeks.
latanoprostDrug
Latanoprost administered in the affected eye(s) as prescribed by physician.

Study groups in NCT01151904
Study group	Role	What they receive
COMBIGAN® with Latanoprost	Experimental	Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks. Receives: Drug: brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution; Drug: latanoprost

What is being measured

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

Change From Baseline in Intraocular Pressure (IOP)
IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.
Measured: Baseline, Week 12

Secondary outcomes (2)

Change From Baseline in IOP
IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.
Measured: Baseline, Week 2, Week 6
Percentage of Responders With an IOP Reduction ≥20% From Baseline
IOP is a measure of the fluid pressure inside the eye. A responder is defined as a patient with a mean IOP reduction of at least 20% in the affected eye(s) from baseline. Due to lack of enrollment, analysis was not performed for this outcome measure.
Measured: Baseline, Week 12

Timeline

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

Nov 2009Feb 2012

First posted29 Jun 2010 (estimated)
Study startNov 2009
Primary completionFeb 2012
Study completionFeb 2012

Why it stopped: Difficulty with patient recruitment

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 Glaucoma, Angle-ClosureStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01151904
Sponsor's protocol ID: MA-COM004
Status last verified: Jan 2013
First submitted: 5 Jun 2010
Last updated: 6 Feb 2013
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, Angle-Closure trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients
ClinicalTrials.gov ID: NCT01151904
Acronym / sponsor ID: MA-COM004
Conditions: Glaucoma, Angle-Closure
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficulty with patient recruitment
Enrolment: 17 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 29 Jun 2010 (estimated)
Results: Posted 6 Feb 2013

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
COMBIGAN® with Latanoprost	Experimental	Drug: brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution, Drug: latanoprostPatients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.

Who may qualify

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

Key inclusion criteria (4 listed)

Patient has been administering latanoprost eye drops in affected eye(s) for at least 12 weeks prior to study
Patient must have at least partially responded to latanoprost and requiring further IOP lowering eye drops
Diagnosis of chronic angle-closure glaucoma
Patients using COMBIGAN® in the past must not have been discontinued due to adverse events or lack of efficacy.

Key exclusion criteria (4 listed)

Known allergy or hypersensitivity to COMBIGAN®
Corneal abnormalities that would preclude accurate IOP readings
Any other active ocular disease other than glaucoma or ocular hypertension
Ocular surgery within the past 3 months.

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 0.2%/timolol 0.5% fixed combination ophthalmic solutionAlso: COMBIGAN®COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) administered as one drop in the morning and one drop in the evening in affected eye(s) for 12 weeks.	Drug	COMBIGAN® with Latanoprost
latanoprostLatanoprost administered in the affected eye(s) as prescribed by physician.	Drug	COMBIGAN® with Latanoprost

Primary outcome

Change From Baseline in Intraocular Pressure (IOP)
Time frame: Baseline, Week 12
IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.

2 secondary outcomes

Change From Baseline in IOP
Time frame: Baseline, Week 2, Week 6
Percentage of Responders With an IOP Reduction ≥20% From Baseline
Time frame: Baseline, Week 12

Results and safety

Results posted to the registry on 6 Feb 2013, 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® With Latanoprost	17	17

Primary outcome: Change From Baseline in Intraocular Pressure (IOP)

Time frame: Baseline, Week 12

Population analysed: Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.

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
COMBIGAN® With Latanoprost	0 of 17 (0%)	5 of 17 (29.4%)	Not reported

Limitations and caveats (from the sponsor): Due to lack of enrollment, this study was discontinued early and the outcome measures were not analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Glaucoma, Angle-Closure

RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
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Not yet recruiting
Combined Phacoemulsification-Goniotomy in Primary Open-Angle and Primary Angle-Closure Glaucoma
Primary Open-Angle Glaucoma, Primary Angle-Closure Glaucoma
RecruitingObservational study
Dresden Glaucoma and Treatment Study (DGTS)
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Not yet recruiting
Testing a Reading Module to Improve Reading Skills and Quality of Life in Glaucoma Patients
Primary Open Angle Glaucoma (POAG), Juvenile Open Angle Glaucoma
Not yet recruitingObservational study
Predicting the Risk of Partial Ciliary Block After Cataract and Goniosynechialysis Surgery in Primary Angle-Closure Disease
Primary Angle-Closure 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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution and latanoprost in people with Glaucoma, Angle-Closure, run by Allergan at 1 site in Thailand.

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 4 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: stopped early, as of the sponsor's last update on 6 Feb 2013. 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 Thailand. 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 6 Feb 2013). 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 Intraocular Pressure (IOP) (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 NCT01151904.

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 6 Feb 2013.