All
children will get a gel to be used twice a day. However,
there is a chance that your child will get a placebo (the
gel without the medication in it). The rest of the children
will get the gel with the medication in it. Children are
assigned by chance either placebo or the treatment gel.
The
medication has been studied extensively in animals and has
been found to be safe when used in the eye. Additionally,
the medication has been safely used in humans as an oral formulation
in countries such as Germany, Japan, England and Canada for
up to 20 years as a treatment for gastric problems.
Your
child will be closely observed and be given regular eye examinations
in our office. We can discuss any concerns that you may have,
as well as the effect of the medication at the completion
of the study.
In previous studies, the medication was well tolerated. Side
effects were mild and included stinging upon instillation
of the medication, pupil dilation and short term blurred
vision.
Copyright @ 1997 - 2008, Valley Forge Pharmaceuticals, Inc.
