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24-hour IOP-lowering Effect of Brimonidine 0.1%

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ClinicalTrials.gov Identifier: NCT00457795
Recruitment Status : Completed
First Posted : April 9, 2007
Results First Posted : November 24, 2011
Last Update Posted : November 24, 2011
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Open-angle Glaucoma
Ocular Hypertension
Intervention Drug: brimonidine 0.1% (Alphagan® P)
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Brimonidine 0.1%
Hide Arm/Group Description Brimonidine 0.1%
Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title Brimonidine 0.1%
Hide Arm/Group Description Brimonidine 0.1%
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
58.3  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
10
  66.7%
Male
5
  33.3%
1.Primary Outcome
Title Intraocular Pressure (IOP) for a 24-Hour Period at Week 4
Hide Description IOP for a 24-hour period separated into diurnal(7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eye. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat defined as all patients who started the study (randomized)
Arm/Group Title Brimonidine 0.1%
Hide Arm/Group Description:
Brimonidine 0.1%
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
Diurnal IOP Sitting at Week 4 16.8  (2.8)
Diurnal IOP Supine at Week 4 21.1  (2.3)
Nocturnal IOP Supine at Week 4 23.0  (2.8)
2.Secondary Outcome
Title Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4
Hide Description Change from baseline in IOP for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eey. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period. A negative number change from baseline indicates an improvement.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat defined as all patients who started the study (randomized)
Arm/Group Title Brimonidine 0.1%
Hide Arm/Group Description:
Brimonidine 0.1%
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
Diurnal IOP Sitting at Baseline 19.2  (2.7)
Diurnal IOP Supine at Baseline 23.1  (2.1)
Nocturnal IOP Supine at Baseline 22.7  (2.6)
Diurnal IOP Sitting Change from Baseline at Week 4 -2.4  (1.4)
Diurnal IOP Supine Change from Baseline at Week 4 -1.9  (1.3)
Nocturnal IOP Supine Change from Baseline at Wk 4 0.3  (1.9)
3.Secondary Outcome
Title Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4
Hide Description Ocular perfusion pressure (OPP) calculated for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat defined as all patients who started the study (randomized)
Arm/Group Title Brimonidine 0.1%
Hide Arm/Group Description:
Brimonidine 0.1%
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
Diurnal OPP Sitting at Week 4 46.8  (7.6)
Diurnal OPP Supine at Week 4 53.8  (9.8)
Nocturnal OPP Supine at Week 4 49.2  (11.2)
4.Secondary Outcome
Title Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4
Hide Description Change in ocular perfusion pressure (OPP) calculated over a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at Week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat defined as all patients who started the study (randomized)
Arm/Group Title Brimonidine 0.1%
Hide Arm/Group Description:
Brimonidine 0.1%
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
Diurnal Change in OPP Sitting at Week 4 1.1  (5.6)
Diurnal Change in OPP Supine at Week 4 0.3  (4.9)
Nocturnal Change in OPP Supine at Week 4 -3.0  (6.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brimonidine 0.1%
Hide Arm/Group Description Brimonidine 0.1%
All-Cause Mortality
Brimonidine 0.1%
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Brimonidine 0.1%
Affected / at Risk (%)
Total   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brimonidine 0.1%
Affected / at Risk (%)
Total   0/15 (0.00%) 
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.
A 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 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President, Medical Affairs
Organization: Allergan, Inc.
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00457795     History of Changes
Other Study ID Numbers: MA-080806-2
First Submitted: April 6, 2007
First Posted: April 9, 2007
Results First Submitted: October 18, 2011
Results First Posted: November 24, 2011
Last Update Posted: November 24, 2011