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. 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 <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. 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.
RCT Entities:
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. 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 <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. 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.
Authors: Jeffrey J Walline; Kristina Lindsley; Satyanarayana S Vedula; Susan A Cotter; Donald O Mutti; J Daniel Twelker Journal: Cochrane Database Syst Rev Date: 2011-12-07
Authors: Leslie Donovan; Padmaja Sankaridurg; Arthur Ho; Thomas Naduvilath; Earl L Smith; Brien A Holden Journal: Optom Vis Sci Date: 2012-01 Impact factor: 1.973
Authors: Andrea Russo; Francesco Semeraro; Mario R Romano; Rodolfo Mastropasqua; Roberto Dell'Omo; Ciro Costagliola Journal: Int Ophthalmol Date: 2013-09-17 Impact factor: 2.031