Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

24-hour IOP-lowering Effect of Brimonidine 0.1%

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: 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

Tracking Information
First Submitted Date  ICMJE April 6, 2007
First Posted Date  ICMJE April 9, 2007
Results First Submitted Date  ICMJE October 18, 2011
Results First Posted Date  ICMJE November 24, 2011
Last Update Posted Date November 24, 2011
Study Start Date  ICMJE December 2006
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2011)
Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 [ Time Frame: Week 4 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2007)
mean IOP for 24-hour period at 4 weeks
Change History Complete list of historical versions of study NCT00457795 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2011)
  • Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 [ Time Frame: Baseline, Week 4 ]
    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.
  • Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4 [ Time Frame: Week 4 ]
    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.
  • Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4 [ Time Frame: Week 4 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2007)
ocular perfusion pressure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 24-hour IOP-lowering Effect of Brimonidine 0.1%
Official Title  ICMJE Not Provided
Brief Summary This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in patients with glaucoma or ocular hypertension
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Open-angle Glaucoma
  • Ocular Hypertension
Intervention  ICMJE Drug: brimonidine 0.1% (Alphagan® P)
Brimonidine 0.1%, 1 drop three-times daily for 4 weeks
Other Name: Alphagan® P
Study Arms  ICMJE Experimental: brimonidine 0.1%
brimonidine 0.1%
Intervention: Drug: brimonidine 0.1% (Alphagan® P)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2007)
15
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • allergy to brimonidine
  • inability to complete 24 hour stay for monitoring
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00457795
Other Study ID Numbers  ICMJE MA-080806-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Affairs Allergan
PRS Account Allergan
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP