Results of the betaxolol versus placebo treatment trial in ocular hypertension

Graefes Arch Clin Exp Ophthalmol. 2003 Mar;241(3):196-203. doi: 10.1007/s00417-002-0614-4. Epub 2003 Feb 19.


Purpose: To determine whether treatment with betaxolol can delay or prevent the conversion from ocular hypertension to early glaucoma on the basis of visual field criteria, by means of a prospective, randomised, placebo-controlled trial.

Methods: Three hundred and fifty-six ocular hypertensives were randomized to treatment with either betaxolol drops or placebo drops during the period 1992-1996. Each patient was followed prospectively with 4-monthly visits. Examination at each visit included visual field testing, intra-ocular pressure (IOP) measurement and optic disc imaging. Conversion to early glaucoma was defined on the basis of visual field change by AGIS criteria. An intent-to-treat analysis compared visual field conversion after 3 years in the treatment and placebo arms. Normal visual field survival analysis was also performed. The IOP characteristics of the two treatment groups were compared.

Results: Two hundred and fifty-five patients completed the study, which ended in 1998, with a range of follow-up of 2-6 years. Sixteen (13.2%) of 121 patients in the placebo group converted to glaucoma, compared with 12 (9.0%) of 134 patients in the betaxolol group. The intent-to-treat analysis demonstrated no evidence of any difference in conversion rates between the betaxolol and placebo groups after 3 years. Visual field survival analysis demonstrated no significant difference between the betaxolol and placebo groups. The betaxolol-treated group had significantly lower post-treatment IOP values. Converters had significantly higher pre- and post-treatment IOP values than non-converters.

Conclusions: Betaxolol significantly lowered the IOP level compared with placebo. Conversion to glaucoma was found to be related to both the baseline and post-treatment IOP levels. However the intent-to-treat analysis did not demonstrate a statistically significant reduction in the conversion rate in the betaxolol-treated group.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenergic beta-Antagonists / administration & dosage
  • Adrenergic beta-Antagonists / therapeutic use*
  • Aged
  • Betaxolol / administration & dosage
  • Betaxolol / therapeutic use*
  • Double-Blind Method
  • Female
  • Glaucoma / diagnosis
  • Glaucoma / prevention & control
  • Humans
  • Intraocular Pressure / drug effects
  • Male
  • Ocular Hypertension / diagnosis
  • Ocular Hypertension / drug therapy*
  • Ophthalmic Solutions
  • Prospective Studies
  • Visual Fields / drug effects


  • Adrenergic beta-Antagonists
  • Ophthalmic Solutions
  • Betaxolol