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Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01177098
First received: August 4, 2010
Last updated: March 22, 2013
Last verified: March 2013
Results First Received: February 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Glaucoma
Ocular Hypertension
Interventions: Drug: bimatoprost /timolol formulation A fixed combination ophthalmic solution
Drug: bimatoprost/timolol fixed combination 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
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Reporting Groups
  Description
Bimatoprost/Timolol Formulation A One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
Bimatoprost/Timolol Fixed Combination Ophthalmic Solution One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.

Participant Flow:   Overall Study
    Bimatoprost/Timolol Formulation A   Bimatoprost/Timolol Fixed Combination Ophthalmic Solution
STARTED   278   283 
COMPLETED   269   271 
NOT COMPLETED   9   12 



  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.
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Reporting Groups
  Description
Bimatoprost/Timolol Formulation A One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
Bimatoprost/Timolol Fixed Combination Ophthalmic Solution One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Total Total of all reporting groups

Baseline Measures
   Bimatoprost/Timolol Formulation A   Bimatoprost/Timolol Fixed Combination Ophthalmic Solution   Total 
Overall Participants Analyzed 
[Units: Participants]
 278   283   561 
Age, Customized 
[Units: Participants]
     
<45 Years   12   13   25 
45 to 65 Years   132   135   267 
>65 Years   134   135   269 
Gender 
[Units: Participants]
     
Female   159   162   321 
Male   119   121   240 


  Outcome Measures
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1.  Primary:   Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12   [ Time Frame: Baseline, Week 12 ]

2.  Primary:   Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2   [ Time Frame: Week 2 ]

3.  Primary:   Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6   [ Time Frame: Week 6 ]

4.  Primary:   Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12   [ Time Frame: Week 12 ]

5.  Secondary:   Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12   [ Time Frame: Baseline, Week 12 ]

6.  Secondary:   Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12   [ 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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01177098     History of Changes
Other Study ID Numbers: 192024-050
2010-021507-24 ( EudraCT Number )
Study First Received: August 4, 2010
Results First Received: February 7, 2013
Last Updated: March 22, 2013
Health Authority: United States: Food and Drug Administration