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Trial record 88 of 154 for:    Brimonidine

Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT01229462
Recruitment Status : Completed
First Posted : October 27, 2010
Results First Posted : September 14, 2012
Last Update Posted : September 14, 2012
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: brimonidine tartrate/timolol fixed combination ophthalmic solution
Drug: brimonidine tartrate ophthalmic solution
Drug: timolol ophthalmic solution
Other: fixed combination vehicle
Enrollment 238
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Combigan® Alphagan® and Timolol Concurrent
Hide Arm/Group Description One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks. One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Period Title: Overall Study
Started 120 118
Completed 115 109
Not Completed 5 9
Arm/Group Title Combigan® Alphagan® and Timolol Concurrent Total
Hide Arm/Group Description One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks. One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks. Total of all reporting groups
Overall Number of Baseline Participants 120 118 238
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 118 participants 238 participants
46.2  (15.18) 48.2  (15.57) 47.2  (15.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 118 participants 238 participants
Female
48
  40.0%
55
  46.6%
103
  43.3%
Male
72
  60.0%
63
  53.4%
135
  56.7%
1.Primary Outcome
Title Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4
Hide Description Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population consisted of all randomized participants.
Arm/Group Title Combigan® Alphagan® and Timolol Concurrent
Hide Arm/Group Description:
One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Overall Number of Participants Analyzed 120 118
Mean (Standard Deviation)
Unit of Measure: mm Hg
Baseline 25.07  (3.737) 24.53  (2.926)
Change from baseline at Week 4 -6.21  (3.550) -5.70  (3.469)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
 
Arm/Group Title Combigan® Alphagan® and Timolol Concurrent
Hide Arm/Group Description One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks. One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
All-Cause Mortality
Combigan® Alphagan® and Timolol Concurrent
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Combigan® Alphagan® and Timolol Concurrent
Affected / at Risk (%) Affected / at Risk (%)
Total   1/120 (0.83%)   1/116 (0.86%) 
Ear and labyrinth disorders     
Sudden hearing loss * 1  1/120 (0.83%)  0/116 (0.00%) 
Nervous system disorders     
VIth nerve paralysis * 1  0/120 (0.00%)  1/116 (0.86%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Combigan® Alphagan® and Timolol Concurrent
Affected / at Risk (%) Affected / at Risk (%)
Total   0/120 (0.00%)   0/116 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01229462     History of Changes
Other Study ID Numbers: 190342-035
First Submitted: October 26, 2010
First Posted: October 27, 2010
Results First Submitted: August 15, 2012
Results First Posted: September 14, 2012
Last Update Posted: September 14, 2012