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Effect of Alphagan on Retinal Blood Flow Autoregulation and Motion Detection in Patients With Normal Pressure Glaucoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01105065
First Posted: April 16, 2010
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Louis Pasquale, MD, Massachusetts Eye and Ear Infirmary
Results First Submitted: December 7, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Glaucoma
Intervention: Drug: brimonidine 0.15%

  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
46 participants enrolled but only 23 had retinal vascular dysregulation.

Reporting Groups
  Description
Patients With RVD

Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.

Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks.


Participant Flow:   Overall Study
    Patients With RVD
STARTED   23 
COMPLETED   17 
NOT COMPLETED   6 
Adverse Event                5 
Technical Problems                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
Patients With RVD

Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.

Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks.


Baseline Measures
   Patients With RVD 
Overall Participants Analyzed 
[Units: Participants]
 23 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 57.1  (10.8) 
[1] age range: 35 years to 80 years
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      12  52.2% 
Male      11  47.8% 
Region of Enrollment 
[Units: Participants]
 
United States   23 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Presence of Retinal Blood Flow Autoregulation   [ Time Frame: 8 weeks ]

2.  Secondary:   Frequency Doubling Perimetry   [ Time Frame: 8 weeks ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Louis R. Pasquale, MD
Organization: Massachusetts Eye and Ear Infirmary
phone: 617-573-4270
e-mail: Louis_Pasquale@meei.harvard.edu


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

Responsible Party: Louis Pasquale, MD, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01105065     History of Changes
Other Study ID Numbers: 10-03-019 (75643)
First Submitted: April 14, 2010
First Posted: April 16, 2010
Results First Submitted: December 7, 2014
Results First Posted: October 27, 2016
Last Update Posted: April 4, 2017