One-year multicenter, double-masked, placebo-controlled, parallel safety and efficacy study of 2% pirenzepine ophthalmic gel in children with myopia
2005; Elsevier BV; Volume: 112; Issue: 1 Linguagem: Inglês
10.1016/j.ophtha.2004.06.038
ISSN1549-4713
AutoresD. Tan, Dennis S.C. Lam, Wei Ling Chua, D SHUPING, R CROCKETT,
Tópico(s)Corneal surgery and disorders
ResumoObjective 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 ≤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. Intervention 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. Main outcome measure 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.
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