Safety and efficacy of 2% pirenzepine ophthalmic gel in children with myopia: a 1-year, multicenter, double-masked, placebo-controlled parallel study.
OBJECTIVE
To evaluate the safety and efficacy of the relatively selective M(1) 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.
Siatkowski
R Michael
RM
Department of Ophthalmology, University of Oklahoma, and Dean A. McGee Eye Institute, Oklahoma City 73104, USA. Rmichael-Siatkowski@ouhsc.edu
Cotter
Susan
S
Miller
Joseph M
JM
Scher
Colin A
CA
Crockett
R Stephens
RS
Novack
Gary D
GD
D002648:Child; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D009216:Myopia / Q000188:drug therapy*; D009883:Ophthalmic Solutions; D010890:Pirenzepine / Q000009:adverse effects / Q000627:therapeutic use*; D012029:Refraction, Ocular / Q000187:drug effects; D012449:Safety; D016896:Treatment Outcome; D014792:Visual Acuity / Q000187:drug effects
D005782:Gels; D018727:Muscarinic Antagonists; D009883:Ophthalmic Solutions; D010890:Pirenzepine