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OpenTrials
Completed

NCT Number: NCT00457795

24-hour IOP-lowering Effect of Brimonidine 0.1%

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

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Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Diego, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with open-angle glaucoma or ocular hypertension

Exclusion criteria

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

Treatment and study plan

brimonidine 0.1% (Alphagan® P)

Drug

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

Other names: Alphagan® P

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Apr 9, 2007
Registry last updated
Nov 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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