A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma

This study has been terminated.
(Study terminated due to corporate decision.)
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01426113
First received: August 29, 2011
Last updated: September 2, 2015
Last verified: September 2015
Results First Received: June 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Glaucoma
Interventions: Drug: bimatoprost ophthalmic solution formulation A
Drug: timolol ophthalmic solution
Drug: bimatoprost vehicle

  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
The study was discontinued prematurely after enrollment of 6 patients.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bimatoprost Ophthalmic Solution Formulation A and Vehicle 1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
Timolol Ophthalmic Solution 1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.

Participant Flow:   Overall Study
    Bimatoprost Ophthalmic Solution Formulation A and Vehicle     Timolol Ophthalmic Solution  
STARTED     3     3  
COMPLETED     2     1  
NOT COMPLETED     1     2  
Study Discontinued                 1                 1  
Adverse Event                 0                 1  



  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
Bimatoprost Ophthalmic Solution Formulation A and Vehicle 1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
Timolol Ophthalmic Solution 1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Bimatoprost Ophthalmic Solution Formulation A and Vehicle     Timolol Ophthalmic Solution     Total  
Number of Participants  
[units: participants]
  3     3     6  
Age, Customized  
[units: Participants]
     
12 to 15 years     3     3     6  
Gender  
[units: Participants]
     
Female     3     0     3  
Male     0     3     3  



  Outcome Measures

1.  Primary:   Change From Baseline in Intraocular Pressure (IOP) in the Study Eye   [ Time Frame: Baseline, Week 6 ]


  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: NCT01426113     History of Changes
Other Study ID Numbers: 192024-056
Study First Received: August 29, 2011
Results First Received: June 29, 2015
Last Updated: September 2, 2015
Health Authority: United States: Food and Drug Administration