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CompletedNCT01177098Updated Mar 29, 2013Results posted

Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

A Phase 3 interventional study of bimatoprost /timolol formulation A fixed combination ophthalmic solution and bimatoprost/timolol fixed combination ophthalmic solution in Glaucoma and Ocular Hypertension, sponsored by Allergan. Completed at 9 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-29.

Sponsored by Allergan · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
561
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.

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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 561 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
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient has ocular hypertension or glaucoma in both eyes
  • Requires IOP-lowering therapy in each eye

Exclusion criteria

Exclusion Criteria:

  • Active or recurrent eye disease that would interfere with interpretation of study data in either eye
  • History of any eye surgery or laser in either eye within 6 months
  • Required chronic use of other eye medications during the study
  • Anticipated wearing of contact lenses during the study.
  • Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
561 participants (actual)

Study arms

  • Experimental
    bimatoprost/timolol formulation A

    One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.

    Drug: bimatoprost /timolol formulation A fixed combination ophthalmic solution

  • Active comparator
    bimatoprost/timolol fixed combination ophthalmic solution

    One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.

    Drug: bimatoprost/timolol fixed combination ophthalmic solution

Interventions

  • Drugbimatoprost /timolol formulation A fixed combination ophthalmic solution

    One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.

  • Drugbimatoprost/timolol fixed combination ophthalmic solution

    One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.

    Also known as: GANFORT®

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12

    Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).

    Time frame: Baseline, Week 12

  2. Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2

    Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8.

    Time frame: Week 2

  3. Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6

    Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8.

    Time frame: Week 6

  4. Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12

    Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8.

    Time frame: Week 12

Secondary outcomes

  1. Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12

    Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).

    Time frame: Baseline, Week 12

  2. Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12

    Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement).

    Time frame: Baseline, Week 12

07

Results

Posted Mar 12, 2013

Participant flow

Participant flow — Overall Study
MilestoneBimatoprost/Timolol Formulation ABimatoprost/Timolol Fixed Combination Ophthalmic Solution
Started278283
Completed269271
Not completed912

Outcome measures

PrimaryChange From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).

Time frame:
Baseline, Week 12
Reported as:
Mean · mm Hg
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
mm HgBimatoprost/Timolol Formulation ABimatoprost/Timolol Fixed Combination Ophthalmic Solution
Baseline_Hour 025.41 ± 2.23225.38 ± 2.209
Baseline_Hour 2 (n=255,260)24.79 ± 2.67624.72 ± 2.470
Baseline_Hour 8 (n=254,259)23.88 ± 3.00823.82 ± 2.747
Change from baseline at Week 12_Hour 0 (n=244,237)-9.06 ± 3.216-8.72 ± 3.088
Change from baseline at Week 12_Hour 2 (n=235,235)-8.53 ± 3.520-8.38 ± 3.297
Change from baseline at Week 12_Hour 8 (n=237,234)-7.98 ± 3.435-7.72 ± 3.172
PrimaryAverage Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8.

Time frame:
Week 2
Reported as:
Mean · mm Hg
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2
mm HgBimatoprost/Timolol Formulation ABimatoprost/Timolol Fixed Combination Ophthalmic Solution
Week 2_Hour 016.23 ± 2.74616.49 ± 2.887
Week 2_Hour 216.05 ± 2.87716.23 ± 2.826
Week 2_Hour 815.49 ± 2.59615.83 ± 2.987
SecondaryChange From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).

Time frame:
Baseline, Week 12
Reported as:
Mean · mm Hg
Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12
mm HgBimatoprost/Timolol Formulation ABimatoprost/Timolol Fixed Combination Ophthalmic Solution
Baseline_Hour 025.34 ± 2.23325.30 ± 2.244
Baseline_Hour 224.71 ± 2.70024.61 ± 2.536
Baseline_Hour 823.81 ± 2.98923.80 ± 2.795
Change from baseline at Week 12_Hour 0-8.94 ± 3.290-8.51 ± 3.253
Change from baseline at Week 12_Hour 2-8.44 ± 3.646-8.08 ± 3.504
Change from baseline at Week 12_Hour 8-7.87 ± 3.496-7.52 ± 3.362
SecondaryChange From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement).

Time frame:
Baseline, Week 12
Reported as:
Mean · mm Hg
Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12
mm HgBimatoprost/Timolol Formulation ABimatoprost/Timolol Fixed Combination Ophthalmic Solution
Baseline_Hour 024.94 ± 2.11624.86 ± 2.131
Baseline_Hour 224.29 ± 2.51524.23 ± 2.426
Baseline_Hour 823.42 ± 2.90423.36 ± 2.703
Change from baseline at Week 12_Hour 0-8.65 ± 3.109-8.30 ± 3.009
Change from baseline at Week 12_Hour 2-8.11 ± 3.392-7.86 ± 3.413
Change from baseline at Week 12_Hour 8-7.57 ± 3.395-7.27 ± 3.226
PrimaryAverage Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8.

Time frame:
Week 6
Reported as:
Mean · mm Hg
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6
mm HgBimatoprost/Timolol Formulation ABimatoprost/Timolol Fixed Combination Ophthalmic Solution
Week 6_Hour 016.28 ± 2.75416.31 ± 2.874
Week 6_Hour 215.90 ± 2.91016.17 ± 2.894
Week 6_Hour 815.71 ± 2.75515.82 ± 2.926
PrimaryAverage Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8.

Time frame:
Week 12
Reported as:
Mean · mm Hg
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
mm HgBimatoprost/Timolol Formulation ABimatoprost/Timolol Fixed Combination Ophthalmic Solution
Week 12_Hour 016.29 ± 2.78316.56 ± 2.643
Week 12_Hour 216.18 ± 2.84516.37 ± 2.699
Week 12_Hour 815.85 ± 2.78616.09 ± 2.714

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Bimatoprost/Timolol Formulation A—4/278 (1.4%)59/278 (21.2%)
Bimatoprost/Timolol Fixed Combination Ophthalmic Solution—4/282 (1.4%)55/282 (19.5%)
Most frequent serious events
Most frequent serious events
EventBimatoprost/Timolol Formulation ABimatoprost/Timolol Fixed Combination Ophthalmic Solution
Intermittent claudicationVascular disorders1/2780/282
Lumbar spinal stenosisMusculoskeletal and connective tissue disorders1/2780/282
OsteoarthritisMusculoskeletal and connective tissue disorders1/2780/282
Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/2780/282
Cerebellar infarctionNervous system disorders0/2781/282
Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/2781/282
Non-Hodgkin's lymphomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/2781/282
Non-cardiac chest painGeneral disorders0/2781/282
Most frequent other events
Most frequent other events
EventBimatoprost/Timolol Formulation ABimatoprost/Timolol Fixed Combination Ophthalmic Solution
Conjunctival hyperaemiaEye disorders59/27855/282

Baseline characteristics

Age, Customized
Age, Customized(Participants)Bimatoprost/Timolol Formulation ABimatoprost/Timolol Fixed Combination Ophthalmic SolutionTotal
<45 Years12 ± 10.6113 ± 10.8225 ± 10.71
45 to 65 Years132135267
>65 Years134135269
Sex: Female, Male
Sex: Female, Male(Participants)Bimatoprost/Timolol Formulation ABimatoprost/Timolol Fixed Combination Ophthalmic SolutionTotal
Female159162321
Male119121240
08

Study locations

9 sites
  • Artesia, California, United States
  • Sydney, New South Wales, Australia
  • Brno, Czech Republic
  • Leipzig, Germany
  • Budapest, Hungary
  • Tel Aviv, Israel
  • Saint-Petersburg, Russian Federation
  • Valencia, Spain
  • London, England, United Kingdom
09

References and documents

Publications

  • Goldberg I, Gil Pina R, Lanzagorta-Aresti A, Schiffman RM, Liu C, Bejanian M. Bimatoprost 0.03%/timolol 0.5% preservative-free ophthalmic solution versus bimatoprost 0.03%/timolol 0.5% ophthalmic solution (Ganfort) for glaucoma or ocular hypertension: a 12-week randomised controlled trial. Br J Ophthalmol. 2014 Jul;98(7):926-31. doi: 10.1136/bjophthalmol-2013-304064. Epub 2014 Mar 25. PubMed 24667994 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01177098
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Aug 6, 2010
Start date
Oct 2010
Primary completion
Feb 2012
Completion
Feb 2012
Results posted
Mar 12, 2013
Last update
Mar 29, 2013

Study contacts

Medical Director
study director · Allergan

Oversight

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

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