May 2003
Volume 44, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2003
Pirenzepine Ophthalmic Gel (PIR): Safety and Efficacy for Pediatric Myopia in a One-Year Study in Asia
Author Affiliations & Notes
  • D.T. Tan
    Singapore Eye Research Institute, Singapore National Eye Center, Dept of Ophthalmology, National University of Singapore, Singapore,
  • D. Lam
    Dept of Ophthalmology & Visual Sciences, Chinese University of Hong Kong, Hong Kong Special Administrative Region of China,
  • W.H. Chua
    Dept of Ophthalmology & Visual Sciences, Chinese University of Hong Kong, Hong Kong Special Administrative Region of China,
  • R.S. Crockett
    D.A.T.A., Inc., Mobile, AL, United States
  • Asian Pirenzepine Study Group
    D.A.T.A., Inc., Mobile, AL, United States
  • Footnotes
    Commercial Relationships  D.T. Tan, Valley Forge Pharmaceuticals, Inc. F; D. Lam, Valley Forge Pharmaceuticals, Inc. F; W.H. Chua, Valley Forge Pharmaceuticals, Inc. F; R.S. Crockett, Valley Forge Pharmaceuticals, Inc. C.
Investigative Ophthalmology & Visual Science May 2003, Vol.44, 801. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      D.T. Tan, D. Lam, W.H. Chua, R.S. Crockett, Asian Pirenzepine Study Group; Pirenzepine Ophthalmic Gel (PIR): Safety and Efficacy for Pediatric Myopia in a One-Year Study in Asia . Invest. Ophthalmol. Vis. Sci. 2003;44(13):801.

      Download citation file:


      © ARVO (1962-2015); The Authors (2016-present)

      ×
  • Supplements
Abstract

Abstract: : Purpose: To determine the safety and efficacy of 2% pirenzepine ophthalmic gel (PIR), a relatively selective muscarinic antagonist; in children by evaluation of refractive error and axial length in a 1-year Asian trial. Methods: This was a multi-center, randomized, double masked placebo-controlled parallel group study conducted in 353 children aged 6 to 12 at 7sites in Asia. Unequal randomization was performed at a ratio of 2:2:1 for treatment with PIR 2% b.i.d., placebo morning + 2% PIR evening, and placebo b.i.d. The primary efficacy measure was cycloplegic autorefraction, and secondarily axial length as measured by ultrasonography. Results: From a mean baseline of -2.3 to -2.4D, differences in favor of PIR were seen starting at 3 months. At the end of 1 year, the mean progression in myopia was -0.47D (PIR b.i.d.), -0.70D (PIR q.d.), and -0.84D (placebo b.i.d.). Probability comparisons were PIR b.i.d. vs. placebo (< 0.001), PIR b.i.d. vs. PIR q.d. (<0.001), and PIR q.d. vs placebo (0.235). The difference between PIR b.i.d. and placebo represents approximately a 50% reduction in progression. At 1 year, the increase in axial length was consistent with refractive changes: PIR bid +0.21 mm, PIR q.d. +0.30 mm, and placebo +0.33 mm. Probability comparisons were PIR b.i.d. vs. placebo (0.005), PIR b.i.d. vs. PIR q.d. (0.024), and PIR q.d. vs. placebo (0.420). Mydriatric and accommodative effects were present, but relatively mild, as were adverse events. However, there was, a dosing-related incidence of follicles and papillae that were often asymptomatic. Conclusions: Pirenzepine showed a statistically significant decrease in myopic progression in children with minimal anti-muscarinic safety issues.

Keywords: myopia • clinical (human) or epidemiologic studies: tre • refractive error development 
×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×