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Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT01241240
Recruitment Status : Completed
First Posted : November 16, 2010
Results First Posted : September 10, 2014
Last Update Posted : September 10, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Glaucoma, Open-Angle
Ocular Hypertension
Interventions Drug: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)
Drug: Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution
Enrollment 192
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Triple Combination Therapy Combigan®
Hide Arm/Group Description Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks. Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
Period Title: Overall Study
Started 94 98
Completed 86 89
Not Completed 8 9
Reason Not Completed
Adverse Event             5             4
Lost to Follow-up             2             4
Personal Reasons             1             1
Arm/Group Title Triple Combination Therapy Combigan® Total
Hide Arm/Group Description Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks. Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 94 98 192
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 98 participants 192 participants
≤65 years 67 74 141
>65 years 27 24 51
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 98 participants 192 participants
Female
78
  83.0%
73
  74.5%
151
  78.6%
Male
16
  17.0%
25
  25.5%
41
  21.4%
1.Primary Outcome
Title Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12
Hide Description IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at week 12. A negative change from Baseline indicated improvement.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the modified Intent-to-treat (mITT) population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.
Arm/Group Title Triple Combination Therapy Combigan®
Hide Arm/Group Description:
Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
Overall Number of Participants Analyzed 93 97
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline (n=93,95) 24.62  (2.475) 25.12  (2.178)
Change from Baseline at Week 12 (n=93,94) -10.03  (2.661) -9.18  (2.566)
2.Secondary Outcome
Title Change From Baseline in Mean Worse Eye IOP
Hide Description IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each visit. A negative change from Baseline indicated improvement.
Time Frame Baseline, Weeks 1, 2, 4 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the mITT population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.
Arm/Group Title Triple Combination Therapy Combigan®
Hide Arm/Group Description:
Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
Overall Number of Participants Analyzed 93 97
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline (n=93,95) 24.62  (2.475) 25.12  (2.178)
Change from Baseline at Week 1 (n=91,89) -10.18  (3.149) -8.90  (3.044)
Change from Baseline at Week 2 (n=88,93) -10.40  (2.802) -9.06  (2.925)
Change from Baseline at Week 4 (n=86,90) -10.06  (2.793) -9.21  (2.306)
Change from Baseline at Week 8 (n=88,89) -9.77  (2.852) -9.02  (2.869)
3.Secondary Outcome
Title Mean Worse Eye IOP
Hide Description IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each time-point.
Time Frame Weeks 1, 2, 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the mITT population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.
Arm/Group Title Triple Combination Therapy Combigan®
Hide Arm/Group Description:
Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
Overall Number of Participants Analyzed 93 97
Mean (Standard Deviation)
Unit of Measure: mmHg
Week 1 (n=91,90) 14.43  (2.785) 16.23  (2.968)
Week 2 (n=88,95) 14.05  (2.634) 16.08  (2.726)
Week 4 (n=86,92) 14.38  (2.587) 15.96  (2.705)
Week 8 (n=88,91) 14.68  (2.709) 16.11  (2.935)
Week 12 (n=86,88) 14.43  (2.344) 15.92  (2.867)
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
 
Arm/Group Title Triple Combination Therapy Combigan®
Hide Arm/Group Description Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks. Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
All-Cause Mortality
Triple Combination Therapy Combigan®
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Triple Combination Therapy Combigan®
Affected / at Risk (%) Affected / at Risk (%)
Total   3/93 (3.23%)   0/98 (0.00%) 
Cardiac disorders     
Bradycardia  1  1/93 (1.08%)  0/98 (0.00%) 
Infections and infestations     
Pyomyositis  1  1/93 (1.08%)  0/98 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pituitary tumour  1  1/93 (1.08%)  0/98 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumothorax  1  1/93 (1.08%)  0/98 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Triple Combination Therapy Combigan®
Affected / at Risk (%) Affected / at Risk (%)
Total   57/93 (61.29%)   25/98 (25.51%) 
Eye disorders     
Conjunctival hyperaemia  1  22/93 (23.66%)  4/98 (4.08%) 
Eye irritation  1  13/93 (13.98%)  4/98 (4.08%) 
Dry eye  1  10/93 (10.75%)  2/98 (2.04%) 
Eye pruritus  1  6/93 (6.45%)  2/98 (2.04%) 
Nervous system disorders     
Somnolence * 1  5/93 (5.38%)  8/98 (8.16%) 
Visual field defect  1  5/93 (5.38%)  5/98 (5.10%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
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. No documents containing confidential information from the sponsor or information developed will be submitted for publication without prior written authorization from the sponsor.
Results Point of Contact
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01241240     History of Changes
Other Study ID Numbers: 192024-063
First Submitted: November 12, 2010
First Posted: November 16, 2010
Results First Submitted: September 4, 2014
Results First Posted: September 10, 2014
Last Update Posted: September 10, 2014