24-hour IOP-lowering Effect of Brimonidine 0.1%

October 18, 2011 updated by: Allergan
This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in patients with glaucoma or ocular hypertension

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: brimonidine 0.1%
Drug: brimonidine 0.1% (Alphagan® P)
Brimonidine 0.1%, 1 drop three-times daily for 4 weeks
Other Names:
  • Alphagan® P

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 4
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.
Week 4
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.
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Medical Affairs, Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

April 6, 2007

First Submitted That Met QC Criteria

April 6, 2007

First Posted (Estimate)

April 9, 2007

Study Record Updates

Last Update Posted (Estimate)

November 24, 2011

Last Update Submitted That Met QC Criteria

October 18, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-080806-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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