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Trial record 13 of 152 for:    Brimonidine

Aqueous Humor Dynamics and Brimonidine (Brimonidine)

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ClinicalTrials.gov Identifier: NCT01144494
Recruitment Status : Completed
First Posted : June 15, 2010
Results First Posted : April 24, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Carol B. Toris, BA MS PhD, University of Nebraska

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Intraocular Pressure
Interventions Drug: Brimonidine
Drug: Artificial tears
Enrollment 35
Recruitment Details  
Pre-assignment Details 2 subjects consented and then dropped out prior to assignment.
Arm/Group Title IOP Lowering Drug Then Art Tears Artificial Tears Then IOP Lowering Drug
Hide Arm/Group Description

Eyedrops for lowering intraocular pressure

Brimonidine: One drop of brimonidine in each eye three times a day for six weeks.

Lubricated eye drops

Artificial tears: Lubricating drops added three times a day for six weeks

Lubricated eye drops

Artificial tears: Lubricating drops added three times a day for six weeks

Eyedrops for lowering intraocular pressure

Brimonidine: One drop of brimonidine in each eye three times a day for six weeks.

Period Title: Overall Study
Started 15 18
Completed 15 14
Not Completed 0 4
Arm/Group Title All Study Participants
Hide Arm/Group Description participants were randomized to receive both IOP lowering drug and lubricating drops in a randomized order
Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
Intraocular pressure, episcleral venous pressure, and aqueous flow were calculated using data from 29 participants. However, tonography/outflow facility data on 2 participants were not reliable, therefore uveosleral outflow and outflow facility analysis were performed on 27 participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants
58.6  (1.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
19
  65.5%
Male
10
  34.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
White
21
  72.4%
African American
6
  20.7%
Hispanic
1
   3.4%
Native American
1
   3.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants
29
1.Primary Outcome
Title Seated Day-time IOP 9 am and 11 am, Supine Day-time IOP 9 am and 11 am, and Seated Night-time IOP 9 pm and 11 pm
Hide Description Seated day-time and supine day-time IOP was measured by pneumatonometer at 9 am and 11 am. Seated night-time IOP was measured at 9 pm and 11 pm.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
some patients were consented but did not participate due to various reasons
Arm/Group Title Intraocular Pressure Lowering Drug Artificial Tears
Hide Arm/Group Description:

Eyedrops for lowering intraocular pressure

Brimonidine: One drop of brimonidine in each eye three times a day for six weeks.

Lubricated eye drops

Artificial tears: Lubricating drops added three times a day for six weeks

Overall Number of Participants Analyzed 29 29
Mean (Standard Error)
Unit of Measure: mmHg
Seated day-time 9 am 18.1  (0.7) 20.3  (0.7)
Seated day-time 11 am 18.0  (0.7) 19.9  (0.8)
Supine day-time 9 am 23.1  (0.7) 25.4  (0.7)
Supine day-time 11 am 23.1  (0.7) 24.7  (0.8)
Seated night-time 9 pm 16.0  (0.6) 18.0  (0.7)
Seated night-time 11 pm 16.7  (0.7) 18.4  (0.7)
2.Primary Outcome
Title Supine Night-time & Day-time Seated Episcleral Venous Pressure (EVP)
Hide Description The episcleral venous pressure was measured using the episcleral venomanometer
Time Frame 6 weeks plus 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
some patients were consented but did not participate due to various reasons
Arm/Group Title Intraocular Pressure Lowering Drug Artificial Tears
Hide Arm/Group Description:

Eyedrops for lowering intraocular pressure

Brimonidine: One drop of brimonidine in each eye three times a day for six weeks.

Lubricated eye drops

Artificial tears: Lubricating drops added three times a day for six weeks

Overall Number of Participants Analyzed 27 27
Mean (Standard Error)
Unit of Measure: mmHg
Daytime Seated 10.3  (0.2) 10.3  (0.2)
Nighttime Supine 11.3  (0.3) 11.2  (0.2)
3.Secondary Outcome
Title Aqueous Flow
Hide Description Measured by fluorophotometry during the day and night on 29 participants.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Measurements were taken in the day and night for each group and analysis was done comparing the difference between and within both groups in the day and night respectively.

some patients were consented but did not participate due to various reasons

Arm/Group Title IOP Lowering Drug Artificial Tears
Hide Arm/Group Description:

Eyedrops for lowering intraocular pressure

Brimonidine: One drop of brimonidine in each eye three times a day for six weeks.

Lubricated eye drops

Artificial tears: Lubricating drops added three times a day for six weeks

Overall Number of Participants Analyzed 29 29
Mean (Standard Error)
Unit of Measure: µl/min
day-time measurement 2.4  (0.1) 2.3  (0.1)
night-time measurement 1.5  (0.1) 1.5  (0.1)
4.Secondary Outcome
Title Uveoscleral Outflow
Hide Description Calculated from the modified Goldmann equation using data obtained at 9 am and 11 am. Goldmann equation involves data from aqueous flow, tonography/outflow facility, episcleral venous pressure and IOP. Tonography/outflow facility data on 2 participants were not reliable, therefore uveosleral outflow analysis was performed on 27 participants.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Tonography/outflow facility data on 2 participants were not reliable, therefore uveosleral outflow analysis was performed on 27 participants.

some patients were consented but did not participate due to various reasons

Arm/Group Title IOP Lowering Drug Artificial Tears
Hide Arm/Group Description:

Eyedrops for lowering intraocular pressure

Brimonidine: One drop of brimonidine in each eye three times a day for six weeks.

Lubricated eye drops

Artificial tears: Lubricating drops added three times a day for six weeks

Overall Number of Participants Analyzed 27 27
Mean (95% Confidence Interval)
Unit of Measure: μL/min
0.84
(0.24 to 1.46)
0.72
(0.11 to 1.34)
5.Secondary Outcome
Title Outflow Facility
Hide Description Calculated from the measurement taken during the day and night. Tonography/outflow facility data was not reliable in 2 of the participants, therefore analysis was conducted on data from 27 participants.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Tonography/outflow facility data was not reliable in 2 of the participants, therefore analysis was conducted on data from 27 participants.

some patients were consented but did not participate due to various reasons

Arm/Group Title IOP Lowering Drug (Day) IOP Lowering Drug (Night) Artificial Tears (Day) Artificial Tears (Night)
Hide Arm/Group Description:

Eyedrops for lowering intraocular pressure

Brimonidine: One drop of brimonidine in each eye three times a day for six weeks.

Eyedrops for lowering intraocular pressure

Brimonidine: One drop of brimonidine in each eye three times a day for six weeks.

Lubricated eye drops

Artificial tears: Lubricating drops added three times a day for six weeks

Lubricated eye drops

Artificial tears: Lubricating drops added three times a day for six weeks

Overall Number of Participants Analyzed 27 27 27 27
Mean (Standard Error)
Unit of Measure: μL/min
0.28  (0.02) 0.28  (0.02) 0.29  (0.02) 0.29  (0.02)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intraocular Pressure Lowering Drug Artificial Tears
Hide Arm/Group Description

Eyedrops for lowering intraocular pressure

Brimonidine: One drop of brimonidine in each eye three times a day for six weeks.

Lubricated eye drops

Artificial tears: Lubricating drops added three times a day for six weeks

All-Cause Mortality
Intraocular Pressure Lowering Drug Artificial Tears
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intraocular Pressure Lowering Drug Artificial Tears
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intraocular Pressure Lowering Drug Artificial Tears
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   4/33 (12.12%) 
Eye disorders     
IOP equal to 35mmHg  0/33 (0.00%)  1/33 (3.03%) 
Acute anterior uveitis  0/33 (0.00%)  3/33 (9.09%) 
Corneal Epitheliopathy  0/33 (0.00%)  1/33 (3.03%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr Carol Toris
Organization: UNMC
Phone: 402-559-1852
Responsible Party: Carol B. Toris, BA MS PhD, University of Nebraska
ClinicalTrials.gov Identifier: NCT01144494     History of Changes
Other Study ID Numbers: 220-10-FB
First Submitted: June 11, 2010
First Posted: June 15, 2010
Results First Submitted: April 24, 2018
Results First Posted: April 24, 2019
Last Update Posted: May 22, 2019