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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

Brief Summary:
This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in patients with glaucoma or ocular hypertension

Condition or disease Intervention/treatment Phase
Open-angle Glaucoma Ocular Hypertension Drug: brimonidine 0.1% (Alphagan® P) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009


Arm Intervention/treatment
Experimental: brimonidine 0.1%
brimonidine 0.1%
Drug: brimonidine 0.1% (Alphagan® P)
Brimonidine 0.1%, 1 drop three-times daily for 4 weeks
Other Name: Alphagan® P



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • allergy to brimonidine
  • inability to complete 24 hour stay for monitoring

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00457795


Locations
United States, California
San Diego, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Affairs Allergan

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00457795     History of Changes
Other Study ID Numbers: MA-080806-2
First Posted: April 9, 2007    Key Record Dates
Results First Posted: November 24, 2011
Last Update Posted: November 24, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Glaucoma
Eye Diseases
Brimonidine Tartrate
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs