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

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.
 
ClinicalTrials.gov Identifier: NCT01105065
Recruitment Status : Completed
First Posted : April 16, 2010
Results First Posted : October 27, 2016
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Louis Pasquale, MD, Massachusetts Eye and Ear Infirmary

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glaucoma
Intervention Drug: brimonidine 0.15%
Enrollment 46
Recruitment Details  
Pre-assignment Details 46 participants enrolled but only 23 had retinal vascular dysregulation.
Arm/Group Title Patients With RVD
Hide Arm/Group Description

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.
Period Title: Overall Study
Started 23
Completed 17
Not Completed 6
Reason Not Completed
Adverse Event             5
Technical Problems             1
Arm/Group Title Patients With RVD
Hide Arm/Group Description

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.
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
57.1  (10.8)
[1]
Measure Description: age range: 35 years to 80 years
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
12
  52.2%
Male
11
  47.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
1.Primary Outcome
Title Presence of Retinal Blood Flow Autoregulation
Hide Description We defined retinal vascular dysregulation based on the percentage change between the retinal blood flow measured while reclining for 30 minutes and the baseline seated measures. In a prior study, we found that healthy subjects exhibited a +6.5%±12% blood flow change induced by 30 minutes of reclining. Thus, we defined the normal range of blood flow autoregulation as within 2 standard deviations of the mean percentage change found in this group, or -17.5% to +30.5%.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With RVD
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: participants
14
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients With RVD
Comments There would be no change in retinal vascular dysregulation after treatment with brimonidine
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
2.Secondary Outcome
Title Frequency Doubling Perimetry
Hide Description Frequency doubling perimetry was measured pre- and post treatment with brimonidine for 8 weeks.We used the full-threshold N-30 protocol to determine the visual field mean deviation, pattern standard deviation, and test duration in the eye that had hemodynamic testing. The results that are reported below are the mean deviation values recorded as part of the frequency doubling perimetry as these are the most significant.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RVD Patients Pre-brimonidine Treatment RVD Patients Post-brimonidine Treatment
Hide Arm/Group Description:
Patients who exhibited retinal vascular dysregulation at the initial visit. The mean deviation frequency doubling perimetry values were measured in these patients before their treatment with brimonidine.
Patients who exhibited retinal vascular dysregulation at the initial visit. The mean deviation frequency doubling perimetry values were measured in these patients after their treatment with brimonidine.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: dB
-2.03  (3.50) -2.77  (5.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RVD Patients Pre-brimonidine Treatment
Comments A paired t-test was used to determine if their was a statistically significant difference between the mean deviation of the frequency doubling perimetry in the RVD patients pre and post brimonidine treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients With RVD
Hide Arm/Group Description

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.
All-Cause Mortality
Patients With RVD
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Patients With RVD
Affected / at Risk (%)
Total   0/23 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patients With RVD
Affected / at Risk (%)
Total   5/23 (21.74%) 
Eye disorders   
Allergic reaction *  5/23 (21.74%) 
*
Indicates events were collected by non-systematic assessment
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Louis R. Pasquale, MD
Organization: Massachusetts Eye and Ear Infirmary
Phone: 617-573-4270
EMail: Louis_Pasquale@meei.harvard.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Louis Pasquale, MD, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01105065    
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