CClinicalTrials.gg
Sign In
CompletedNCT01863953Updated Jan 26, 2015Results posted

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

A Phase 2 interventional study of Fixed-Combination Bimatoprost/Brimonidine and Bimatoprost Ophthalmic Solution 0.01% in Glaucoma and Ocular Hypertension, sponsored by Allergan. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2015-01-26.

Sponsored by Allergan · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Glaucoma
  • Ocular Hypertension
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 112 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
112 participants (actual)

Study arms

  • Experimental
    Fixed-Combination Bimatoprost/Brimonidine

    One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.

    Drug: Fixed-Combination Bimatoprost/Brimonidine

  • Active comparator
    Bimatoprost Ophthalmic Solution 0.01% and Vehicle

    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.

    Drug: Bimatoprost Ophthalmic Solution 0.01% · Drug: Vehicle Ophthalmic Solution

  • Active comparator
    Brimonidine Tartrate Ophthalmic Solution 0.2%

    One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.

    Drug: Brimonidine Tartrate Ophthalmic Solution 0.2%

Interventions

  • DrugFixed-Combination Bimatoprost/Brimonidine

    One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.

  • DrugBimatoprost Ophthalmic Solution 0.01%

    One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening for 6 weeks.

    Also known as: LUMIGAN

  • DrugVehicle Ophthalmic Solution

    One drop vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.

  • DrugBrimonidine Tartrate Ophthalmic Solution 0.2%

    One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.

    Also known as: ALPHAGAN

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline, Day 42

Secondary outcomes

  1. 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).

    Time frame: Baseline, Day 14, Day 28

  2. 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.

    Time frame: Day 14, Day 28, Day 42

07

Results

Posted Jan 26, 2015

Participant flow

Participant flow — Overall Study
MilestoneFixed-Combination Bimatoprost/BrimonidineBimatoprost Ophthalmic Solution 0.01% and VehicleBrimonidine Tartrate Ophthalmic Solution 0.2%
Started383638
Completed383637
Not completed001
Withdrew: Adverse event001

Outcome measures

PrimaryChange 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).

Time frame:
Baseline, Day 42
Reported as:
Mean · Millimeters of Mercury (mmHg)
Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)
Millimeters of Mercury (mmHg)Fixed-Combination Bimatoprost/BrimonidineBimatoprost Ophthalmic Solution 0.01% and VehicleBrimonidine Tartrate Ophthalmic Solution 0.2%
Baseline24.54 ± 1.71224.38 ± 2.02224.29 ± 1.457
Change from Baseline at Day 42 (N=38, 36, 37)-6.79 ± 2.277-6.63 ± 2.284-3.92 ± 2.574
SecondaryChange 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).

Time frame:
Baseline, Day 14, Day 28
Reported as:
Mean · mmHg
Change From Baseline in Average Eye Mean Diurnal IOP
mmHgFixed-Combination Bimatoprost/BrimonidineBimatoprost Ophthalmic Solution 0.01% and VehicleBrimonidine Tartrate Ophthalmic Solution 0.2%
Baseline24.54 ± 1.71224.38 ± 2.02224.29 ± 1.457
Change from Baseline at Day 14-7.63 ± 2.152-6.79 ± 1.997-4.67 ± 2.944
Change from Baseline at Day 28-7.25 ± 2.328-6.98 ± 2.260-4.22 ± 2.869
SecondaryAverage 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.

Time frame:
Day 14, Day 28, Day 42
Reported as:
Mean · mmHg
Average Eye Mean Diurnal IOP
mmHgFixed-Combination Bimatoprost/BrimonidineBimatoprost Ophthalmic Solution 0.01% and VehicleBrimonidine Tartrate Ophthalmic Solution 0.2%
Day 1416.91 ± 2.00417.59 ± 2.36319.61 ± 2.572
Day 2817.29 ± 2.58817.40 ± 2.54920.06 ± 2.540
Day 42 (N=38, 36, 37)17.75 ± 2.50517.76 ± 2.46720.34 ± 2.218

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Fixed-Combination Bimatoprost/Brimonidine—0/38 (0%)27/38 (71.1%)
Bimatoprost Ophthalmic Solution 0.01% and Vehicle—1/36 (2.8%)25/36 (69.4%)
Brimonidine Tartrate Ophthalmic Solution 0.2%—1/38 (2.6%)20/38 (52.6%)
Most frequent serious events
Most frequent serious events
EventFixed-Combination Bimatoprost/BrimonidineBimatoprost Ophthalmic Solution 0.01% and VehicleBrimonidine Tartrate Ophthalmic Solution 0.2%
Breast CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/381/360/38
Acute Myocardial InfarctionCardiac disorders0/380/361/38
Most frequent other events
Showing 10 of 14
Most frequent other events
EventFixed-Combination Bimatoprost/BrimonidineBimatoprost Ophthalmic Solution 0.01% and VehicleBrimonidine Tartrate Ophthalmic Solution 0.2%
Conjunctival HyperaemiaEye disorders18/3816/362/38
Eye PruritusEye disorders5/385/363/38
Punctate KeratitisEye disorders2/384/362/38
Dry MouthGastrointestinal disorders0/381/364/38
Eye IrritationEye disorders0/383/361/38
Eye DischargeEye disorders3/381/361/38
BlepharospasmEye disorders3/380/360/38
NasopharyngitisInfections and infestations0/382/360/38
Eye PainEye disorders2/381/362/38
Instillation Site PruritusGeneral disorders2/381/360/38

Baseline characteristics

Age, Customized
Age, Customized(Participants)Fixed-Combination Bimatoprost/BrimonidineBimatoprost Ophthalmic Solution 0.01% and VehicleBrimonidine Tartrate Ophthalmic Solution 0.2%Total
<45 years1001
Between 45 and 65 years21142055
>65 years16221856
Sex: Female, Male
Sex: Female, Male(Participants)Fixed-Combination Bimatoprost/BrimonidineBimatoprost Ophthalmic Solution 0.01% and VehicleBrimonidine Tartrate Ophthalmic Solution 0.2%Total
Female20222567
Male18141345
08

Study locations

1 site
  • Newport Beach, California, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01863953
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
May 29, 2013
Start date
Jun 2013
Primary completion
Dec 2013
Completion
Dec 2013
Results posted
Jan 26, 2015
Last update
Jan 26, 2015

Study contacts

Medical Director
study director · Allergan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Glaucoma→

Other studies from this sponsor

Allergan

Start the discussion