24-hour IOP-lowering Effect of Brimonidine 0.1%

Phase 4

Completed

• Conditions: Open-angle Glaucoma; Ocular Hypertension
• Interventions: Drug: brimonidine 0.1% (Alphagan® P)

• Registration Number: NCT00457795
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-04-06
• Study First Submitted QC: 2007-04-06
• Study First Posted: 2007-04-09
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2011-10
• Results First Submitted: 2011-10-18
• Results First Submitted QC: 2011-10-18
• Last Update Submitted: 2011-10-18
• Results First Posted: 2011-11-24
• Last Update Posted: 2011-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• patients with open-angle glaucoma or ocular hypertension

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
brimonidine 0.1%	brimonidine 0.1% (Alphagan® P)	brimonidine 0.1%

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP) for a 24-Hour Period at Week 4	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

Name	Time	Method
Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4	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	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	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.