One-year multicenter, double-masked, placebo-controlled, parallel safety and efficacy study of 2% pirenzepine ophthalmic gel in children with myopia.

OBJECTIVE: To evaluate the safety and efficacy of the relatively selective M(1)-antagonist, pirenzepine ophthalmic gel (gel), in slowing the progression of myopia in school-aged children. DESIGN: Parallel-group, placebo-controlled, randomized, double-masked study. PARTICIPANTS: Three hundred fifty-three healthy children, 6 to 12 years old, with a spherical equivalent (SE) of -0.75 to -4.00 diopters (D) and astigmatism of