Circadian Ocular Perfusion Pressure and Ocular Blood Flow

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00800540
First received: December 1, 2008
Last updated: March 20, 2013
Last verified: March 2013
Results First Received: January 31, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Glaucoma
Interventions: Drug: Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension
Drug: Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops 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
Participants were recruited from and enrolled at one study center located in Greece.

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
AZARGA/COMBIGAN AZARGA, followed by COMBIGAN, as randomized. Each fixed combination was used for 6 weeks, with a 4-week washout period separating the two treatment periods.
COMBIGAN/AZARGA COMBIGAN, followed by AZARGA, as randomized. Each fixed combination was used for 6 weeks, with a 4-week washout period separating the two treatment periods.

Participant Flow for 3 periods

Period 1:   Period One: 6 Weeks
    AZARGA/COMBIGAN     COMBIGAN/AZARGA  
STARTED     17     18  
COMPLETED     16     17  
NOT COMPLETED     1     1  
Noncompliance                 1                 0  
Pt Decision Unrelated to Adverse Event                 0                 1  

Period 2:   Washout: 4 Weeks
    AZARGA/COMBIGAN     COMBIGAN/AZARGA  
STARTED     16     17  
COMPLETED     16     17  
NOT COMPLETED     0     0  

Period 3:   Period 2: 6 Weeks
    AZARGA/COMBIGAN     COMBIGAN/AZARGA  
STARTED     16     17  
COMPLETED     16     16  
NOT COMPLETED     0     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.
This reporting group includes all enrolled participants.

Reporting Groups
  Description
Overall All enrolled

Baseline Measures
    Overall  
Number of Participants  
[units: participants]
  35  
Age  
[units: years]
Mean ± Standard Deviation
  65.2  ± 10.3  
Gender  
[units: participants]
 
Female     19  
Male     16  
Region of Enrollment  
[units: participants]
 
Greece     35  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6   [ Time Frame: Week 0, Week 6 (period-based) ]

2.  Secondary:   Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6   [ Time Frame: Week 0, Week 6 (period-based) ]

3.  Secondary:   Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6   [ Time Frame: Week 0, Week 6 (period-based) ]

4.  Secondary:   Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6   [ Time Frame: Week 0, Week 6 (period-based) ]

5.  Secondary:   Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6   [ Time Frame: Week 0, Week 6 (period-based) ]

6.  Secondary:   Mean Change From Baseline in Diastolic Blood Pressure at Week 6   [ Time Frame: Week 0, Week 6 (period-based) ]

7.  Secondary:   Mean Change From Baseline in Systolic Blood Pressure at Week 6   [ Time Frame: Week 0, Week 6 (period-based) ]

8.  Secondary:   Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6   [ Time Frame: Week 0, Week 6 (period-based) ]

9.  Secondary:   Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks   [ Time Frame: Week 0, Week 6 (period-based) ]

10.  Secondary:   Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6   [ Time Frame: Week 0, Week 6 (period-based) ]

11.  Secondary:   Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6   [ Time Frame: Week 0, Week 6 (period-based) ]

12.  Secondary:   Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6   [ Time Frame: Week 0, Week 6 (period-based) ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Director, Global Medical Affairs
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00800540     History of Changes
Other Study ID Numbers: C-07-16, 2007-005936-99
Study First Received: December 1, 2008
Results First Received: January 31, 2013
Last Updated: March 20, 2013
Health Authority: Greece: Ethics Committee