Two-year multicenter, randomized, double-masked, placebo-controlled, parallel safety and efficacy study of 2% pirenzepine ophthalmic gel in children with myopia

R. Michael Siatkowski, Susan A. Cotter, R. S. Crockett, Joseph M Miller, Gary D. Novack, Karla Zadnik

Research output: Contribution to journalArticle

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Abstract

Purpose: To evaluate if the safety and efficacy of the relatively selective M1-antagonist, pirenzepine, in slowing the progression of myopia in children is sustained over a 2-year period. Methods: This was a multicenter, parallel-group, placebo-controlled, double-masked, randomized clinical trial. Enrolled were children aged 8 to 12 years, with entry spherical equivalent refractive error of -0.75 to -4.00 D and astigmatism ≤1.00 D. Patients were randomized in a 2:1 ratio to receive 2% pirenzepine ophthalmic gel or a placebo control (vehicle), twice daily to each eye. The main outcome measure was spherical equivalent refractive error via cycloplegic autorefraction. Results: At study entry, spherical equivalent was -2.10 ± 0.90 D (mean ± SD) for the pirenzepine group (n = 117) and -1.93 ± 0.83 D for the placebo group (n = 57; p = 0.22). At 1 year, there was a mean increase in myopia of 0.26 D in the pirenzepine group versus 0.53 D in the placebo group (p < 0.001). Eighty-four patients elected to continue for a second year (pirenzepine = 53, placebo = 31). At 2 years, the mean increase in myopia was 0.58 D for the pirenzepine group and 0.99 D for the placebo group (p = 0.008). Thirteen (11%) pirenzepine patients dropped out due to adverse effects in the first year, and 1 did so in the second year. Conclusions: Pirenzepine ophthalmic gel 2% was effective compared with placebo in slowing the progression of myopia over a 2-year treatment period and demonstrated a clinically acceptable safety profile.{A figure is presented}.

Original languageEnglish (US)
Pages (from-to)332-339
Number of pages8
JournalJournal of AAPOS
Volume12
Issue number4
DOIs
StatePublished - Aug 2008

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Pirenzepine
Myopia
Gels
Placebos
Safety
Refractive Errors
Mydriatics
Astigmatism
Randomized Controlled Trials
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Ophthalmology

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Two-year multicenter, randomized, double-masked, placebo-controlled, parallel safety and efficacy study of 2% pirenzepine ophthalmic gel in children with myopia. / Siatkowski, R. Michael; Cotter, Susan A.; Crockett, R. S.; Miller, Joseph M; Novack, Gary D.; Zadnik, Karla.

In: Journal of AAPOS, Vol. 12, No. 4, 08.2008, p. 332-339.

Research output: Contribution to journalArticle

Siatkowski, R. Michael ; Cotter, Susan A. ; Crockett, R. S. ; Miller, Joseph M ; Novack, Gary D. ; Zadnik, Karla. / Two-year multicenter, randomized, double-masked, placebo-controlled, parallel safety and efficacy study of 2% pirenzepine ophthalmic gel in children with myopia. In: Journal of AAPOS. 2008 ; Vol. 12, No. 4. pp. 332-339.
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abstract = "Purpose: To evaluate if the safety and efficacy of the relatively selective M1-antagonist, pirenzepine, in slowing the progression of myopia in children is sustained over a 2-year period. Methods: This was a multicenter, parallel-group, placebo-controlled, double-masked, randomized clinical trial. Enrolled were children aged 8 to 12 years, with entry spherical equivalent refractive error of -0.75 to -4.00 D and astigmatism ≤1.00 D. Patients were randomized in a 2:1 ratio to receive 2{\%} pirenzepine ophthalmic gel or a placebo control (vehicle), twice daily to each eye. The main outcome measure was spherical equivalent refractive error via cycloplegic autorefraction. Results: At study entry, spherical equivalent was -2.10 ± 0.90 D (mean ± SD) for the pirenzepine group (n = 117) and -1.93 ± 0.83 D for the placebo group (n = 57; p = 0.22). At 1 year, there was a mean increase in myopia of 0.26 D in the pirenzepine group versus 0.53 D in the placebo group (p < 0.001). Eighty-four patients elected to continue for a second year (pirenzepine = 53, placebo = 31). At 2 years, the mean increase in myopia was 0.58 D for the pirenzepine group and 0.99 D for the placebo group (p = 0.008). Thirteen (11{\%}) pirenzepine patients dropped out due to adverse effects in the first year, and 1 did so in the second year. Conclusions: Pirenzepine ophthalmic gel 2{\%} was effective compared with placebo in slowing the progression of myopia over a 2-year treatment period and demonstrated a clinically acceptable safety profile.{A figure is presented}.",
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AU - Cotter, Susan A.

AU - Crockett, R. S.

AU - Miller, Joseph M

AU - Novack, Gary D.

AU - Zadnik, Karla

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AB - Purpose: To evaluate if the safety and efficacy of the relatively selective M1-antagonist, pirenzepine, in slowing the progression of myopia in children is sustained over a 2-year period. Methods: This was a multicenter, parallel-group, placebo-controlled, double-masked, randomized clinical trial. Enrolled were children aged 8 to 12 years, with entry spherical equivalent refractive error of -0.75 to -4.00 D and astigmatism ≤1.00 D. Patients were randomized in a 2:1 ratio to receive 2% pirenzepine ophthalmic gel or a placebo control (vehicle), twice daily to each eye. The main outcome measure was spherical equivalent refractive error via cycloplegic autorefraction. Results: At study entry, spherical equivalent was -2.10 ± 0.90 D (mean ± SD) for the pirenzepine group (n = 117) and -1.93 ± 0.83 D for the placebo group (n = 57; p = 0.22). At 1 year, there was a mean increase in myopia of 0.26 D in the pirenzepine group versus 0.53 D in the placebo group (p < 0.001). Eighty-four patients elected to continue for a second year (pirenzepine = 53, placebo = 31). At 2 years, the mean increase in myopia was 0.58 D for the pirenzepine group and 0.99 D for the placebo group (p = 0.008). Thirteen (11%) pirenzepine patients dropped out due to adverse effects in the first year, and 1 did so in the second year. Conclusions: Pirenzepine ophthalmic gel 2% was effective compared with placebo in slowing the progression of myopia over a 2-year treatment period and demonstrated a clinically acceptable safety profile.{A figure is presented}.

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