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A 1-Year, Multicenter, Double-Masked, Placebo-Controlled Parallel Study

R. Michael Siatkowski, MD; Susan Cotter, OD; Joseph M. Miller, MD; Colin A. Scher, MD; R. Stephens Crockett, PhD; Gary D. Novack, PhD; for the US Pirenzepine Study Group

Arch Ophthalmol. 2004;122:1667-1674.

Objective  To evaluate the safety and efficacy of the relatively selective M₁ antagonist pirenzepine hydrochloride in slowing the progression of myopia in school-aged children.

Methods  This was a parallel-group, placebo-controlled, double-masked study in healthy children, aged 8 to 12 years, with a spherical equivalent of –0.75 to –4.00 diopters (D) and astigmatism of 1.00 D or less. Patients underwent a baseline complete eye examination and regular examinations during a 1-year period. The setting was 13 US academic clinics and private practices. Patients were randomized in a 2:1 ratio to receive 2% pirenzepine ophthalmic gel or a placebo control twice daily for 1 year.

Results  At study entry, the spherical equivalent was mean ± SD –2.098 ± 0.903 D for the pirenzepine group (n = 117) and –1.933 ± 0.825 D for the placebo group (n = 57, P = .22). At 1 year, there was a mean increase in myopia of 0.26 D in the pirenzepine group vs 0.53 D in the placebo group (P < .001). No patients in the placebo group and 13 (11%) of 117 patients in the pirenzepine group discontinued participation in the study because of adverse effects (5 [4%] of 117 due to excessive antimuscarinic effects).

Conclusions  Pirenzepine is effective and relatively safe in slowing the progression of myopia during a 1-year treatment period.

Author Affiliations: Department of Ophthalmology, University of Oklahoma, and Dean A. McGee Eye Institute, Oklahoma City (Dr Siatkowski); Southern California College of Optomety, Fullerton (Dr Cotter); Departments of Ophthalmology, Optical Sciences, and Public Health, University of Arizona, Tucson (Dr Miller); Department of Ophthalmology, Children’s Hospital and Health Center, San Diego, Calif (Dr Scher); D.A.T.A., Inc, Mobile, Ala (Dr Crockett); and PharmaLogic Development, Inc, San Rafael, Calif (Dr Novack).

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