24-hour IOP-lowering Effect of Brimonidine 0.1%

Allergan15 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Open-angle Glaucoma Ocular Hypertension

Interventions

brimonidine 0.1% (Alphagan® P)DRUG

Brimonidine 0.1%, 1 drop three-times daily for 4 weeks

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients with open-angle glaucoma or ocular hypertension Exclusion Criteria: * allergy to brimonidine * inability to complete 24 hour stay for monitoring

Locations (1)

Unnamed facility

San Diego, California, United States

Outcomes

Primary Outcomes

Intraocular Pressure (IOP) for a 24-Hour Period at 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.

Time frame: Week 4

Secondary Outcomes

Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at 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.

Time frame: Baseline, Week 4

Ocular Perfusion Pressure (OPP) for a 24-Hour Period at 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.

Time frame: Week 4

Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at 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.

Data from ClinicalTrials.gov

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