Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01110499
First received: April 23, 2010
Last updated: July 10, 2014
Last verified: July 2014
Results First Received: May 31, 2013  
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
Conditions: Ocular Hypertension
Primary Open-Angle Glaucoma
Interventions: Drug: AGN-210961 Formulation 1
Drug: AGN-210961 Formulation 2
Drug: AGN-210961 Formulation 3
Drug: AGN-210961 Formulation 4
Drug: AGN-210961 Formulation 5
Drug: AGN-210961 Formulation 6
Drug: AGN-210961 Formulation 7
Drug: bimatoprost ophthalmic solution 0.03%

  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 was a 2-part study. Patients were enrolled in and completed Part 1 of the study. Then, based on a review of the data from Part 1, a different formulation was selected for Part 2 (Formulation 7). New patients were then enrolled in Part 2 of the study. No patients from Part 1 were enrolled in Part 2 of the study.

Reporting Groups
  Description
Part 1, AGN-210961 Formulation 1 AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 2 AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 3 AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 4 AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 5 AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 6 AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 2, AGN-210961 Formulation 7 AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
Part 2, Bimatoprost Ophthalmic Solution 0.03% bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.

Participant Flow:   Overall Study
    Part 1, AGN-210961 Formulation 1     Part 1, AGN-210961 Formulation 2     Part 1, AGN-210961 Formulation 3     Part 1, AGN-210961 Formulation 4     Part 1, AGN-210961 Formulation 5     Part 1, AGN-210961 Formulation 6     Part 2, AGN-210961 Formulation 7     Part 2, Bimatoprost Ophthalmic Solution 0.03%  
STARTED     14     14     14     14     14     14     39     40  
COMPLETED     14     14     14     14     14     14     39     40  
NOT COMPLETED     0     0     0     0     0     0     0     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
Part 1, AGN-210961 Formulation 1 AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 2 AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 3 AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 4 AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 5 AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 6 AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 2, AGN-210961 Formulation 7 AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
Part 2, Bimatoprost Ophthalmic Solution 0.03% bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
Total Total of all reporting groups

Baseline Measures
    Part 1, AGN-210961 Formulation 1     Part 1, AGN-210961 Formulation 2     Part 1, AGN-210961 Formulation 3     Part 1, AGN-210961 Formulation 4     Part 1, AGN-210961 Formulation 5     Part 1, AGN-210961 Formulation 6     Part 2, AGN-210961 Formulation 7     Part 2, Bimatoprost Ophthalmic Solution 0.03%     Total  
Number of Participants  
[units: participants]
  14     14     14     14     14     14     39     40     163  
Age, Customized  
[units: Participants]
                 
<45 years     0     1     1     1     0     0     0     1     4  
45 to 65 years     11     3     6     8     6     7     18     23     82  
>65 years     3     10     7     5     8     7     21     16     77  
Gender  
[units: Participants]
                 
Female     12     9     10     9     7     7     24     27     105  
Male     2     5     4     5     7     7     15     13     58  



  Outcome Measures
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1.  Primary:   Part 1: Change From Baseline in Intraocular Pressure (IOP)   [ Time Frame: Baseline, Day 7 ]

2.  Primary:   Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)   [ Time Frame: Baseline, Day 29 ]


  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
No text entered.


  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: NCT01110499     History of Changes
Other Study ID Numbers: 210961-002
Study First Received: April 23, 2010
Results First Received: May 31, 2013
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration