GlaucomaPhase 2NCT01863953

A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension

A Phase 2 study testing Fixed-Combination Bimatoprost/Brimonidine, Bimatoprost Ophthalmic Solution 0.01% and Brimonidine Tartrate Ophthalmic Solution 0.2% 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

This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Glaucoma, Ocular Hypertension
What is being tested?: Fixed-Combination Bimatoprost/Brimonidine, Bimatoprost Ophthalmic Solution 0.01% and Brimonidine Tartrate Ophthalmic Solution 0.2%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: 1 siteUnited States
Study dates: Jun 2013to Dec 2013
Phase: Phase 2
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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of ocular hypertension or glaucoma
Requires intraocular pressure (IOP)-lowering therapy

Who cannot join

Cataract surgery in one eye
Ocular laser or intraocular surgery within 6 months
Refractive surgery in either eye
Anticipated use of contact lenses during the study
Expected use of artificial tears during the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Newport Beach, California

Other trials in United States

About this study

This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.

Conditions: Glaucoma, Ocular Hypertension
Being tested: Fixed-Combination Bimatoprost/Brimonidine, Bimatoprost Ophthalmic Solution 0.01%, Vehicle Ophthalmic Solution, Brimonidine Tartrate Ophthalmic Solution 0.2%
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 Bimatoprost/BrimonidineDrug
One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
Bimatoprost Ophthalmic Solution 0.01%Drug
Also called LUMIGAN
One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening for 6 weeks.
Vehicle Ophthalmic SolutionDrug
One drop vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
Brimonidine Tartrate Ophthalmic Solution 0.2%Drug
Also called ALPHAGAN
One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.

Study groups in NCT01863953
Study group	Role	What they receive
Fixed-Combination Bimatoprost/Brimonidine	Experimental	One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks. Receives: Drug: Fixed-Combination Bimatoprost/Brimonidine
Bimatoprost Ophthalmic Solution 0.01% and Vehicle	Active comparator	One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks. Receives: Drug: Bimatoprost Ophthalmic Solution 0.01%; Drug: Vehicle Ophthalmic Solution
Brimonidine Tartrate Ophthalmic Solution 0.2%	Active comparator	One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks. Receives: Drug: Brimonidine Tartrate Ophthalmic Solution 0.2%

What is being measured

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

Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
Measured: Baseline, Day 42

Secondary outcomes (2)

Change From Baseline in Average Eye Mean Diurnal IOP
IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
Measured: Baseline, Day 14, Day 28
Average Eye Mean Diurnal IOP
IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12.
Measured: Day 14, Day 28, Day 42

Timeline

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

Jun 2013Dec 2013

First posted29 May 2013 (estimated)
Study startJun 2013
Primary completionDec 2013
Study completionDec 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.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01863953
Sponsor's protocol ID: 192024-082
Status last verified: Jan 2015
First submitted: 24 May 2013
Last updated: 26 Jan 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?

See locations

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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT01863953
Acronym / sponsor ID: 192024-082
Conditions: Glaucoma, Ocular Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Jun 2013
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 29 May 2013 (estimated)
Results: Posted 26 Jan 2015

Clinical summary

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

This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Fixed-Combination Bimatoprost/Brimonidine	Experimental	Drug: Fixed-Combination Bimatoprost/BrimonidineOne drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
Bimatoprost Ophthalmic Solution 0.01% and Vehicle	Active comparator	Drug: Bimatoprost Ophthalmic Solution 0.01%, Drug: Vehicle Ophthalmic SolutionOne drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
Brimonidine Tartrate Ophthalmic Solution 0.2%	Active comparator	Drug: Brimonidine Tartrate Ophthalmic Solution 0.2%One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis of ocular hypertension or glaucoma
Requires intraocular pressure (IOP)-lowering therapy

Key exclusion criteria (5 listed)

Cataract surgery in one eye
Ocular laser or intraocular surgery within 6 months
Refractive surgery in either eye
Anticipated use of contact lenses during the study
Expected use of artificial tears 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
Fixed-Combination Bimatoprost/BrimonidineOne drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.	Drug	Fixed-Combination Bimatoprost/Brimonidine
Bimatoprost Ophthalmic Solution 0.01%Also: LUMIGANOne drop bimatoprost ophthalmic solution 0.01% in each eye in the evening for 6 weeks.	Drug	Bimatoprost Ophthalmic Solution 0.01% and Vehicle
Vehicle Ophthalmic SolutionOne drop vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.	Drug	Bimatoprost Ophthalmic Solution 0.01% and Vehicle
Brimonidine Tartrate Ophthalmic Solution 0.2%Also: ALPHAGANOne drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.	Drug	Brimonidine Tartrate Ophthalmic Solution 0.2%

Primary outcome

Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)
Time frame: Baseline, Day 42
IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).

2 secondary outcomes

Change From Baseline in Average Eye Mean Diurnal IOP
Time frame: Baseline, Day 14, Day 28
Average Eye Mean Diurnal IOP
Time frame: Day 14, Day 28, Day 42

Results and safety

Results posted to the registry on 26 Jan 2015, 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 Bimatoprost/Brimonidine	38	38
Bimatoprost Ophthalmic Solution 0.01% and Vehicle	36	36
Brimonidine Tartrate Ophthalmic Solution 0.2%	38	37

Primary outcome: Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)

Time frame: Baseline, Day 42. Mean (Standard Deviation). Unit: Millimeters of Mercury (mmHg)

Measure	Fixed-Combination Bimatoprost/Brimonidine n = 38	Bimatoprost Ophthalmic Solution 0.01% and Vehicle n = 36	Brimonidine Tartrate Ophthalmic Solution 0.2% n = 38
Baseline	24.54 (1.712)	24.38 (2.022)	24.29 (1.457)
Change from Baseline at Day 42 (N=38, 36, 37)	-6.79 (2.277)	-6.63 (2.284)	-3.92 (2.574)

Population analysed: Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment

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
Fixed-Combination Bimatoprost/Brimonidine	0 of 38 (0%)	27 of 38 (71.1%)	Not reported
Bimatoprost Ophthalmic Solution 0.01% and Vehicle	1 of 36 (2.8%)	25 of 36 (69.4%)	Not reported
Brimonidine Tartrate Ophthalmic Solution 0.2%	1 of 38 (2.6%)	20 of 38 (52.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
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 5 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 26 Jan 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 26 Jan 2015). 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 Average Eye Mean Diurnal Intraocular Pressure (IOP) (time frame: Baseline, Day 42). 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 NCT01863953.

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 26 Jan 2015.