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Pediatric Myopia (Nearsightedness)

Pediatric Myopia (Nearsightedness)

Low
Dose Atropine for the Treatment of Myopia (Nearsightedness) in Children

What
is the purpose of this study?

The purpose of this study is to
determine if an investigational eye drop, known as SYD-101, is safe and effective
in slowing the worsening of nearsightedness (myopia) in children compared with
a control treatment. SYD-101 is a new formulation of an approved drug,
atropine, in very low doses of 0.01% and 0.03% concentrations. The currently
FDA approved atropine drops are used for eye exams in order to perform dilated
eye exams and relax the muscles in the eye. These new concentrations mean that
it is an investigational drug that is no approved by the United States Food and
Drug Administration (FDA). There is no marketed medication to slow the
worsening of myopia, although 2 medical societies (American Academy of
Ophthalmology and World Society of Pediatric Ophthalmology and Strabismus) have
endorsed the use of atropine 0.01%, which is available only at compounding pharmacies.

How
many people will receive the drop?

All participants in this study will
use a drop once a day at bedtime. However, participants will be randomly
assigned by a computer to receive either SYD-101 0.01% formulation, SYD-101
0.03% formulation, or a Vehicle (which is a control drop with no active
ingredient). After 36 months of study participation, all patients will be
re-randomized. Some patients will continue in the group they were originally
assigned, while others will start a different drop. All participants will have
the chance to receive active treatment during the study.

Will
the patient know which drop they are using?

Neither the patients nor doctors
will know which group they are assigned to throughout the entire study.

Who
can participate in this trial?

A total of approximately 840 male
and female pediatric participants with myopia, who are in good general health,
and between 3 and 14 years of age will be enrolled in this study.

How
long with the trial last?

The duration of participation will
be approximately 48 months. There are a total of 10 to 11 office visits over
this timeframe, and routine phone calls (approximately 7) from study
coordinators in between office visits.

What
will it cost?

All study related care and study
medications are provided at no cost to the participant. Participants will be
compensated for their time as well as receive a yearly stipend for study
required glasses/contacts.

For more information on this
particular study please see the resources below:

CLINICALTRIALS.GOV

SYDNEXIS.COM

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