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24-hour IOP-lowering Effect of Brimonidine 0.1%

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00457795
First received: April 6, 2007
Last updated: October 18, 2011
Last verified: October 2011
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 15
Study Start Date: December 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457795

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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00457795     History of Changes
Other Study ID Numbers: MA-080806-2
Study First Received: April 6, 2007
Results First Received: October 18, 2011
Last Updated: October 18, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013