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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: August 24, 2016
Last verified: August 2016
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
Patients were randomized into a 12-week Initial Treatment phase. Following this phase, patients may have continued into the 9-month Masked Extension on the same treatment assignment.

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 in the Initial Treatment Phase followed by a 9 month Masked Extension.
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 in the Initial Treatment Phase followed by a 9 month Masked Extension.

Participant Flow for 2 periods

Period 1:   Initial Treatment Phase
    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 

Period 2:   9-Month Masked Extension
    Triple Combination Therapy   Combigan®
STARTED   67   73 
Not Enrolled in Masked Extension   9   10 
COMPLETED   54   62 
NOT COMPLETED   13   11 
Adverse Event                3                6 
Other Reasons                4                4 
Personal Reasons                2                1 
Lost to Follow-up                1                0 
Pregnancy                1                0 
Lack of Efficacy                2                0 



  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 up to 12 months.
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 up to 12 months.
Total Total of all reporting groups

Baseline Measures
   Triple Combination Therapy   Combigan®   Total 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test   [ Time Frame: Baseline, Week 12 ]

2.  Secondary:   Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure   [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12 ]

3.  Secondary:   Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Analysis of Covariance (ANCOVA)   [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 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



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: August 24, 2016
Health Authority: Brazil: National Health Surveillance Agency (ANVISA)