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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01177098
Recruitment Status : Completed
First Posted : August 6, 2010
Results First Posted : March 12, 2013
Last Update Posted : March 29, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Glaucoma
Ocular Hypertension
Interventions Drug: bimatoprost /timolol formulation A fixed combination ophthalmic solution
Drug: bimatoprost/timolol fixed combination ophthalmic solution
Enrollment 561
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bimatoprost/Timolol Formulation A Bimatoprost/Timolol Fixed Combination Ophthalmic Solution
Hide Arm/Group Description One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks. One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Period Title: Overall Study
Started 278 283
Completed 269 271
Not Completed 9 12
Arm/Group Title Bimatoprost/Timolol Formulation A Bimatoprost/Timolol Fixed Combination Ophthalmic Solution Total
Hide Arm/Group Description One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks. One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 278 283 561
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 278 participants 283 participants 561 participants
<45 Years 12 13 25
45 to 65 Years 132 135 267
>65 Years 134 135 269
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 278 participants 283 participants 561 participants
Female
159
  57.2%
162
  57.2%
321
  57.2%
Male
119
  42.8%
121
  42.8%
240
  42.8%
1.Primary Outcome
Title Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population included randomized participants who did not have a protocol violation that significantly affected the conduct or the results of the trial.
Arm/Group Title Bimatoprost/Timolol Formulation A Bimatoprost/Timolol Fixed Combination Ophthalmic Solution
Hide Arm/Group Description:
One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Overall Number of Participants Analyzed 256 260
Mean (Standard Deviation)
Unit of Measure: mm Hg
Baseline_Hour 0 25.41  (2.232) 25.38  (2.209)
Baseline_Hour 2 (n=255,260) 24.79  (2.676) 24.72  (2.470)
Baseline_Hour 8 (n=254,259) 23.88  (3.008) 23.82  (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)
2.Primary Outcome
Title Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population included all randomized participants.
Arm/Group Title Bimatoprost/Timolol Formulation A Bimatoprost/Timolol Fixed Combination Ophthalmic Solution
Hide Arm/Group Description:
One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Overall Number of Participants Analyzed 278 283
Mean (Standard Deviation)
Unit of Measure: mm Hg
Week 2_Hour 0 16.23  (2.746) 16.49  (2.887)
Week 2_Hour 2 16.05  (2.877) 16.23  (2.826)
Week 2_Hour 8 15.49  (2.596) 15.83  (2.987)
3.Primary Outcome
Title Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population included all randomized participants.
Arm/Group Title Bimatoprost/Timolol Formulation A Bimatoprost/Timolol Fixed Combination Ophthalmic Solution
Hide Arm/Group Description:
One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Overall Number of Participants Analyzed 278 283
Mean (Standard Deviation)
Unit of Measure: mm Hg
Week 6_Hour 0 16.28  (2.754) 16.31  (2.874)
Week 6_Hour 2 15.90  (2.910) 16.17  (2.894)
Week 6_Hour 8 15.71  (2.755) 15.82  (2.926)
4.Primary Outcome
Title Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population included all randomized participants.
Arm/Group Title Bimatoprost/Timolol Formulation A Bimatoprost/Timolol Fixed Combination Ophthalmic Solution
Hide Arm/Group Description:
One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Overall Number of Participants Analyzed 278 283
Mean (Standard Deviation)
Unit of Measure: mm Hg
Week 12_Hour 0 16.29  (2.783) 16.56  (2.643)
Week 12_Hour 2 16.18  (2.845) 16.37  (2.699)
Week 12_Hour 8 15.85  (2.786) 16.09  (2.714)
5.Secondary Outcome
Title Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population included all randomized participants.
Arm/Group Title Bimatoprost/Timolol Formulation A Bimatoprost/Timolol Fixed Combination Ophthalmic Solution
Hide Arm/Group Description:
One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Overall Number of Participants Analyzed 278 283
Mean (Standard Deviation)
Unit of Measure: mm Hg
Baseline_Hour 0 25.34  (2.233) 25.30  (2.244)
Baseline_Hour 2 24.71  (2.700) 24.61  (2.536)
Baseline_Hour 8 23.81  (2.989) 23.80  (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)
6.Secondary Outcome
Title Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population included all randomized participants.
Arm/Group Title Bimatoprost/Timolol Formulation A Bimatoprost/Timolol Fixed Combination Ophthalmic Solution
Hide Arm/Group Description:
One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Overall Number of Participants Analyzed 278 283
Mean (Standard Deviation)
Unit of Measure: mm Hg
Baseline_Hour 0 24.94  (2.116) 24.86  (2.131)
Baseline_Hour 2 24.29  (2.515) 24.23  (2.426)
Baseline_Hour 8 23.42  (2.904) 23.36  (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)
Time Frame [Not Specified]
Adverse Event Reporting Description The safety population (all treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
 
Arm/Group Title Bimatoprost/Timolol Formulation A Bimatoprost/Timolol Fixed Combination Ophthalmic Solution
Hide Arm/Group Description One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks. One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
All-Cause Mortality
Bimatoprost/Timolol Formulation A Bimatoprost/Timolol Fixed Combination Ophthalmic Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Bimatoprost/Timolol Formulation A Bimatoprost/Timolol Fixed Combination Ophthalmic Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   4/278 (1.44%)   4/282 (1.42%) 
General disorders     
Non-cardiac chest pain † 1  0/278 (0.00%)  1/282 (0.35%) 
Musculoskeletal and connective tissue disorders     
Lumbar spinal stenosis † 1  1/278 (0.36%)  0/282 (0.00%) 
Osteoarthritis † 1  1/278 (0.36%)  0/282 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate cancer † 1  1/278 (0.36%)  0/282 (0.00%) 
Lung neoplasm malignant † 1  0/278 (0.00%)  1/282 (0.35%) 
Non-Hodgkin's lymphoma † 1  0/278 (0.00%)  1/282 (0.35%) 
Nervous system disorders     
Cerebellar infarction † 1  0/278 (0.00%)  1/282 (0.35%) 
Vascular disorders     
Intermittent claudication * 1  1/278 (0.36%)  0/282 (0.00%) 
†
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bimatoprost/Timolol Formulation A Bimatoprost/Timolol Fixed Combination Ophthalmic Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   59/278 (21.22%)   55/282 (19.50%) 
Eye disorders     
Conjunctival hyperaemia † 1  59/278 (21.22%)  55/282 (19.50%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01177098    
Other Study ID Numbers: 192024-050
2010-021507-24 ( EudraCT Number )
First Submitted: August 4, 2010
First Posted: August 6, 2010
Results First Submitted: February 7, 2013
Results First Posted: March 12, 2013
Last Update Posted: March 29, 2013