"Brimonidine Study" from Glaucoma Associates of Texas

Glaucoma Patient Studies

STUDY: Brimonidine Study

PRIMARY INVESTIGATOR: Dr. Godfrey

PURPOSE OF STUDY:

The purpose of this study is to compare the safety and effectiveness of the 0.2% brimonidine tartrate/0.5% timolol combination (brimonidine/timolol combination) in the treatment of glaucoma and ocular hypertension (elevated pressure in the eye). The brimonidine/timolol combination, used twice daily will be compared with 0.5% timolol twice daily or Alphagan (0.2% brimonidine tartrate) three-times-daily. There is approximately a 33% chance that you will be assigned to receive the 0.2% brimonidine tartrate/0.5% timolol combination.

Neither you nor the study doctor will know which medication you are given, but in case of an emergency, access to that information can be obtained. Approximately 560 patients are expected to participate in this study.

INCLUSION CRITERIA:

To be considered for enrollment into the study you MUST:

Be at least 18 years of age.

Have glaucoma or ocular hypertension in each eye.

Require treatment with anti-glaucoma/ocular hypotensive agents.

Have a negative pregnancy test result, for women of childbearing potential.

Understand and be able to follow the study instructions.

EXCLUSION CRITERIA:

You will not be able to participate in the study if you are a woman who is pregnant, nursing, planning a pregnancy or if you are a woman of childbearing potential, not using a reliable means of contraception. Clinical studies have not been conducted in pregnant women. You will NOT be able to participate in the study IF:

You have an uncontrolled systemic disease.

You have abnormally low or high blood pressure or heart rate for your age or you cannot take medication due to lung disease (obstructive pulmonary disease, bronchial asthma), slow heart rate (sinus bradycardia), irregular heart rate (second degree heart block or worse) or heart dysfunction congestive heart failure).

You are currently taking medication, which can have a great effect on your eye pressure (e.g., propranolol,metoprolol, nadolol, timolol, and atenolol), and you expect to change

You wear contact lenses during the study.

You have participated in a research study ending within 30 days of the start of this study.

COMPENSATION

You will receive compensation for participation in this study. Compensation for participation in this study will be a total of $750.00 upon completion. If you withdraw for unforeseen personal reasons or circumstances preventing further participation, you will receive a prorated compensation for each scheduled visit made to the clinic as follows:

$100.00 at the Pre-Study Visit

$100.00 at the Day 0 Visit

$100.00 at the Week 2 and Week 6 Visit

$100.00 at the Month 3 and Month 6 Visit

$50.00 at the Month 9 Visit

$100.00 at the Month 12 Visit

There are a total of eight visits in a one year period of time.

If you are interested in learning more about one of our Glaucoma Studies, please call Michelle Cochran at 214-360-0000 ext. 126 or email her at mcochran@medsynergies.com.

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Glaucoma Associates of Texas
7150 Greenville Avenue, Suite 300
Dallas, TX 75231
Office: 214-360-0000
Fax: 214-360-0083