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.


METHODS
Parallel-group, placebo-controlled, randomized, double-masked study.


METHODS
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 <or=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.


METHODS
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.


METHODS
Spherical equivalent under cycloplegic refraction.


RESULTS
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<0.001 for gel/gel vs. placebo/placebo). Discontinued from the study for adverse events were 11% (31/282) of pirenzepine-treated subjects. Of the 15 serious adverse events reported in 12 subjects (all in the active groups), none was ophthalmic in nature, all subjects recovered, and only 1 (abdominal colic preceded by a flu) was judged possibly related to treatment.


CONCLUSIONS
Gel (2% twice daily) was effective and relatively safe in slowing the progression of myopia over a 1-year treatment period.
Tan
Donald T H
DT
Singapore Eye Research Institute and Singapore National Eye Centre, Singapore. snecdt@pacific.net.sg <snecdt@pacific.net.sg>
Lam
Dennis S
DS
Chua
Wei Han
WH
Shu-Ping
Dorothy Fan
DF
Crockett
R Stephens
RS
D000293:Adolescent; D002648:Child; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D018727:Muscarinic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D009216:Myopia / Q000188:drug therapy* / Q000503:physiopathology; D009883:Ophthalmic Solutions / Q000008:administration & dosage; D010890:Pirenzepine / Q000008:administration & dosage* / Q000009:adverse effects; D012449:Safety; D014792:Visual Acuity
D005782:Gels; D018727:Muscarinic Antagonists; D009883:Ophthalmic Solutions; D010890:Pirenzepine