Glaucoma Patient Studies

 
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:

  • Under 6 years of age

  • Signed informed consent (parent or legal guardian)

  • Have primary open angle glaucoma or ocular hypertension

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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