Phenylephrine prodrug. Report of clinical trials

Ophthalmology. 1991 Feb;98(2):222-6.

Abstract

The authors evaluated the mydriatic effect of phenylephrine oxazolidine prodrug, a lipophilic sympathomimetic that undergoes hydrolysis to phenylephrine as it passes through the cornea and aqueous humor. Double-masked clinical trials were performed randomizing 66 healthy subjects to receive either the silicone vehicle as a placebo, 10% viscous phenylephrine hydrochloride (HCl), or prodrug in 0.25%, 0.50%, or 1.0% concentrations. A mean horizontal pupillary diameter of 8.8 mm was achieved in 30 minutes in those receiving 1% prodrug versus 6.5 mm obtained at 30 minutes with 10% viscous phenylephrine HCl. Statistically, this difference was highly significant at P less than or equal to 0.0001. There were minimal systemic or ocular adverse effects from any preparation.

Publication types

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

MeSH terms

  • Administration, Topical
  • Adult
  • Anterior Eye Segment / drug effects
  • Blood Pressure / drug effects
  • Double-Blind Method
  • Female
  • Fundus Oculi
  • Heart Rate / drug effects
  • Humans
  • Male
  • Mydriatics / pharmacology*
  • Phenylephrine / analogs & derivatives*
  • Phenylephrine / pharmacology
  • Prodrugs / pharmacology*
  • Pupil / drug effects*
  • Somatotypes

Substances

  • Mydriatics
  • Prodrugs
  • Phenylephrine
  • berefrine