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Safety and Efficacy of Triple Combination Therapy in Patients With Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT01216943
Recruitment Status : Completed
First Posted : October 7, 2010
Results First Posted : September 19, 2013
Last Update Posted : September 19, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Glaucoma
Ocular Hypertension
Intervention Drug: bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution
Enrollment 126
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Triple Combination Therapy
Hide Arm/Group Description One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
Period Title: Overall Study
Started 126
Completed 113
Not Completed 13
Arm/Group Title Triple Combination Therapy
Hide Arm/Group Description One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
Overall Number of Baseline Participants 126
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 126 participants
<45 years 11
45 to 65 years 84
>65 years 31
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants
Female
48
  38.1%
Male
78
  61.9%
1.Primary Outcome
Title Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye
Hide Description IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. 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, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: includes all qualified patients with a baseline and at least 1 postbaseline efficacy evaluation
Arm/Group Title Triple Combination Therapy
Hide Arm/Group Description:
One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
Overall Number of Participants Analyzed 121
Mean (Standard Deviation)
Unit of Measure: Millimeters of Mercury (mmHg)
Baseline 22.35  (3.417)
Change from Baseline at Week 12 -3.98  (2.856)
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all qualified treated patients.
 
Arm/Group Title Triple Combination Therapy
Hide Arm/Group Description One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
All-Cause Mortality
Triple Combination Therapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Triple Combination Therapy
Affected / at Risk (%)
Total   0/121 (0.00%) 
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
Affected / at Risk (%)
Total   20/121 (16.53%) 
Eye disorders   
Conjunctival Hyperaemia  1  20/121 (16.53%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 15.0
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 and can embargo communications regarding trial results for a period that is less than or equal to 30 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
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01216943     History of Changes
Other Study ID Numbers: 192024-049
First Submitted: October 6, 2010
First Posted: October 7, 2010
Results First Submitted: July 16, 2013
Results First Posted: September 19, 2013
Last Update Posted: September 19, 2013