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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01217606
First received: October 7, 2010
Last updated: October 12, 2015
Last verified: October 2015
Results First Received: October 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study is currently reported for the initial treatment period only, as analysis of the masked extension data is pending.

Reporting Groups
  Description
Triple Combination Therapy 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.
Combigan® 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.

Participant Flow:   Overall Study
    Triple Combination Therapy     Combigan®  
STARTED     90     95  
COMPLETED     76     83  
NOT COMPLETED     14     12  
Other Reasons                 0                 2  
Protocol Violation                 3                 2  
Personal Reasons                 0                 2  
Lack of Efficacy                 1                 0  
Adverse Event                 10                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Triple Combination Therapy 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.
Combigan® 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 Total of all reporting groups

Baseline Measures
    Triple Combination Therapy     Combigan®     Total  
Number of Participants  
[units: participants]
  90     95     185  
Age, Customized  
[units: Participants]
     
≤65 years     68     62     130  
>65 years     22     33     55  
Gender  
[units: Participants]
     
Female     53     63     116  
Male     37     32     69  



  Outcome Measures

1.  Primary:   Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP)   [ Time Frame: Baseline, Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only 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 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only 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 more than 60 days but less than or equal to 180 days. 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
e-mail: clinicaltrials@allergan.com


No publications provided


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01217606     History of Changes
Other Study ID Numbers: 192024-062
Study First Received: October 7, 2010
Results First Received: October 12, 2015
Last Updated: October 12, 2015
Health Authority: Brazil: National Health Surveillance Agency (ANVISA)