May 2003
Volume 44, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2003
Randomized, Controlled, One-Year Treatment Comparison of Timolol-LA (ISTALOLTM) Given q.d. vs Timolol Maleate Solution Given b.i.d. in Patients With Ocular Hypertension or Open-Angle Glaucoma
Author Affiliations & Notes
  • G.D. Novack
    PharmaLogic Development Inc, San Rafael, CA, United States
  • T.K. Mundorf
    Charlotte, NC, United States
  • T. Ogawa
    Senju Pharmaceutical Co., Ltd., Osaka, Japan
  • R.S. Crockett
    D.A.T.A., Inc., Mobile, AL, United States
  • US ISTALOL Study Group
    D.A.T.A., Inc., Mobile, AL, United States
  • Footnotes
    Commercial Relationships  G.D. Novack, Senju Pharmaceutical Co., Ltd. C; T.K. Mundorf, Senju Pharmaceutical Co., Ltd. F; T. Ogawa, Senju Pharmaceutical Co., Ltd. E; R.S. Crockett, Senju Pharmaceutical Co., Ltd. C.
  • Footnotes
    Support  Senju Pharmaceutical Co., Ltd.
Investigative Ophthalmology & Visual Science May 2003, Vol.44, 2203. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      G.D. Novack, T.K. Mundorf, T. Ogawa, R.S. Crockett, US ISTALOL Study Group; Randomized, Controlled, One-Year Treatment Comparison of Timolol-LA (ISTALOLTM) Given q.d. vs Timolol Maleate Solution Given b.i.d. in Patients With Ocular Hypertension or Open-Angle Glaucoma . Invest. Ophthalmol. Vis. Sci. 2003;44(13):2203.

      Download citation file:


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

      ×
  • Supplements
Abstract

Abstract: : Purpose: Previously, Timolol-LA (TLA, ISTALOL), an investigational drug, was reported safe when used topically in humans (Novack et al, ARVO 2002). In the present study, the long-term efficacy and safety of once-daily TLA, a unique formulation of timolol containing potassium sorbate, was compared to twice-daily timolol maleate ophthalmic solution (TIM). Methods: In a double-masked, 12 month study patients with ocular hypertension or open-angle glaucoma were randomized to either 0.5% TLA q.d. (AM) and vehicle q.d. (PM), or 0.5% TIM, b.i.d. Results: The 332 patients were 80% Caucasian, 13% Black and 7% other; 61% female; and 60% aged 65 years or greater. At baseline, the unmedicated mean IOP was 25 mm Hg. Following treatment, the mean IOP in both treatment groups decreased to 19-20 mm Hg at trough (↓5-6 mm Hg, ↓20-24%) and 18-19 mm Hg at peak (↓6-7 mm Hg, ↓24-28%). In the equivalency analysis, at none of the visits did the 95% confidence intervals for between treatment comparisons exceed 1.5 mm Hg, and at most of the visits, the intervals did not exceed 1.0 mm Hg. Adverse events were as expected from a topical ß-blocker, and similar between TLA and TIM, with the exception of a differential incidence of burning and stinging (42% for TLA, 23% for TIM). Nearly all of these events were rated as mild (97% with TLA, 90% with TIM). No patients discontinued study treatment due to burning and stinging. Conclusions: TLA 0.5%, once-daily, was an effective 24-hour ocular hypotensive agent, and equivalent to TIM 0.5%, twice-daily, at both peak and trough through this 12 month study. The ocular and systemic safety of TLA was similar to that of TIM, with the exception of a greater incidence of burning and stinging of mild severity with TLA.

Keywords: pharmacology • intraocular pressure 
×
×

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.

×