Efficacy and safety of rimexolone 1% ophthalmic suspension vs 1% prednisolone acetate in the treatment of uveitis

Am J Ophthalmol. 1996 Aug;122(2):171-82. doi: 10.1016/s0002-9394(14)72008-2.

Abstract

Purpose: Two multicenter studies compared the efficacy and safety of rimexolone 1% ophthalmic suspension (Vexol 1%, Alcon) and 1% prednisolone acetate (Pred Forte, Allergan).

Methods: Patients with acute uveitis, recurrent iridocyclitis, or chronic uveitis treatable by topical corticosteroid were enrolled. Treatment regimen was one or two drops every hour during Week 1, every two hours during Week 2, four times a day during Week 3, and once a day for the last three days. Efficacy and safety were determined on Days 3, 4, 7 to 10, 14, 21, and 28. A poststudy evaluation was conducted 36 to 72 hours after treatment was stopped.

Results: When anterior chamber cell and flare were measured, rimexolone 1% was found to be as effective as 1% prednisolone. The largest difference observed between treatments was 0.5 score unit, not clinically significant. There were no statistically significant differences in cell scores in either study (P > .05). No statistically significant differences in flare scores were found except at Day 28 in Study One (P = .04). Also, prednisolone was found to be more likely than rimexolone to cause a clinically significant increase (10 mm Hg or more) in intraocular pressure (1.7 times more likely in Study One, eight times more likely in Study Two).

Conclusion: Rimexolone 1% ophthalmic suspension is safe and effective for the treatment of uveitis.

Publication types

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

MeSH terms

  • Acute Disease
  • Administration, Topical
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anterior Chamber / drug effects
  • Anterior Chamber / pathology
  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / adverse effects
  • Anti-Inflammatory Agents / therapeutic use*
  • Child
  • Chronic Disease
  • Double-Blind Method
  • Female
  • Humans
  • Intraocular Pressure / drug effects
  • Male
  • Middle Aged
  • Ophthalmic Solutions
  • Prednisolone / administration & dosage
  • Prednisolone / adverse effects
  • Prednisolone / therapeutic use*
  • Pregnadienes / administration & dosage
  • Pregnadienes / adverse effects
  • Pregnadienes / therapeutic use*
  • Recurrence
  • Safety
  • Suspensions
  • Uveitis / drug therapy*

Substances

  • Anti-Inflammatory Agents
  • Ophthalmic Solutions
  • Pregnadienes
  • Suspensions
  • Prednisolone
  • rimexolone