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

Abstract

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. Parallel-group, placebo-controlled, randomized, double-masked study. 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 ≤1.00 D. Subjects underwent a baseline complete eye examination, and regular examinations over a 1-year period. The study was conducted at 7 academic centers and clinical practices in Asia. Subjects received 2% gel twice daily (gel/gel), 2% gel daily (evening, placebo/gel), or vehicle twice daily (placebo/placebo) in a 2:2:1 ratio, respectively, for 1 year. Spherical equivalent under cycloplegic refraction. At study entry, mean SE refraction was -2.4±0.9 D. At 12 months, there was a mean increase in myopia of 0.47 D, 0.70 D, and 0.84 D in the gel/gel, placebo/gel, and placebo/placebo groups, respectively (P