Safety and efficacy of 2% pirenzepine ophthalmic gel in children with myopia: A 1-year, multiccntcr, double-masked, placebo-controlled parallel study

R. Michael Siatkowski, Susan Cotter, Joseph M Miller, Colin A. Scher, R. Stephens Crockett, Gary D. Novack

Research output: Contribution to journalArticle

81 Citations (Scopus)

Abstract

Objective: To evaluate the safety and efficacy of the relatively selective M1 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.

Original languageEnglish (US)
Pages (from-to)1667-1674
Number of pages8
JournalArchives of Ophthalmology
Volume122
Issue number11
DOIs
StatePublished - Nov 2004

Fingerprint

Pirenzepine
Gels
Placebos
Safety
Myopia
Muscarinic Antagonists
Astigmatism
Private Practice
Double-Blind Method
Myopia 1

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Safety and efficacy of 2% pirenzepine ophthalmic gel in children with myopia : A 1-year, multiccntcr, double-masked, placebo-controlled parallel study. / Siatkowski, R. Michael; Cotter, Susan; Miller, Joseph M; Scher, Colin A.; Crockett, R. Stephens; Novack, Gary D.

In: Archives of Ophthalmology, Vol. 122, No. 11, 11.2004, p. 1667-1674.

Research output: Contribution to journalArticle

Siatkowski, R. Michael ; Cotter, Susan ; Miller, Joseph M ; Scher, Colin A. ; Crockett, R. Stephens ; Novack, Gary D. / Safety and efficacy of 2% pirenzepine ophthalmic gel in children with myopia : A 1-year, multiccntcr, double-masked, placebo-controlled parallel study. In: Archives of Ophthalmology. 2004 ; Vol. 122, No. 11. pp. 1667-1674.
@article{6d7027fe8a4d4be4882ef14ae54bf2a4,
title = "Safety and efficacy of 2{\%} pirenzepine ophthalmic gel in children with myopia: A 1-year, multiccntcr, double-masked, placebo-controlled parallel study",
abstract = "Objective: To evaluate the safety and efficacy of the relatively selective M1 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.",
author = "Siatkowski, {R. Michael} and Susan Cotter and Miller, {Joseph M} and Scher, {Colin A.} and Crockett, {R. Stephens} and Novack, {Gary D.}",
year = "2004",
month = "11",
doi = "10.1001/archopht.122.11.1667",
language = "English (US)",
volume = "122",
pages = "1667--1674",
journal = "JAMA Ophthalmology",
issn = "2168-6165",
publisher = "American Medical Association",
number = "11",

}

TY - JOUR

T1 - Safety and efficacy of 2% pirenzepine ophthalmic gel in children with myopia

T2 - A 1-year, multiccntcr, double-masked, placebo-controlled parallel study

AU - Siatkowski, R. Michael

AU - Cotter, Susan

AU - Miller, Joseph M

AU - Scher, Colin A.

AU - Crockett, R. Stephens

AU - Novack, Gary D.

PY - 2004/11

Y1 - 2004/11

N2 - Objective: To evaluate the safety and efficacy of the relatively selective M1 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.

AB - Objective: To evaluate the safety and efficacy of the relatively selective M1 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.

UR - http://www.scopus.com/inward/record.url?scp=8144228992&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=8144228992&partnerID=8YFLogxK

U2 - 10.1001/archopht.122.11.1667

DO - 10.1001/archopht.122.11.1667

M3 - Article

C2 - 15534128

AN - SCOPUS:8144228992

VL - 122

SP - 1667

EP - 1674

JO - JAMA Ophthalmology

JF - JAMA Ophthalmology

SN - 2168-6165

IS - 11

ER -