STUDY: Pediatric Glaucoma
PRIMARY INVESTIGATOR:
Dr. Godfrey
PURPOSE OF STUDY:
To document an acceptable safety profile for
initial therapy with dorzolamide and timolol eye drops for up to 3
months in patients who are less than 6 years old, who have elevated
IOP (intraocular pressure) or glaucoma. A combination of timolol and
dorzolamide will also be studied.
Neither you nor the study doctor will know which
medication you are given, however, in the event of an emergency,
that information can be obtained.
DURATION OF SUBJECT
PARTICIPATION:
There will be about 5 visits over a 12-14 week
period. Medical and ocular hisory will be obtained. A complete eye
exam including looking at the front and back of the eye through
dilation. The size of the cornea will be measured along with IOP
measurements, (pressure inside the eye). Two blood samples will be
taken to determine the level of bicarbonate. A report card will be
given to the parent to complete.
INCLUSION CRITERIA:
To be considered for enrollment into the study
you must:
EXCLUSION CRITERIA:
Your child should NOT be in the study if ANY of
the following apply.
-
Your child is currently wearing continuous
wear contact lenses
-
Eye surgery within the last 3 months prior
to the Screening visit.
-
Has had an eye infection within the last
month prior to Screening visit.
-
Is taking medications such as steroids or
scopolamine
-
Is allergic to sulfa drugs
-
Has a history of asthma, chronic lung
disease, or serious heart problems
-
Has kidney disease
COMPENSATION:
The study exams and medication will be of no
charge to you or your insurance company. For you participation in
the study, you will be paid $25.00 per completed study visit. An
additional $20.00 gift certificate for Toys R Us will be given to
your child.
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
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© Glaucoma Associates of Texas 2000-2003
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