Ocular-hypertensive and anti-inflammatory response to rimexolone therapy in children

Arch Ophthalmol. 2003 Dec;121(12):1716-21. doi: 10.1001/archopht.121.12.1716.

Abstract

Objective: To compare the ocular-hypertensive and anti-inflammatory response to rimexolone (116-hydroxy-16alphafluoro-6alphamethylpresdnisolone) and fluorometholone (21-deoxy-9alphafluoro-6alphamethylprednisolone) therapy in children's eyes.

Methods: With parental consent, children who underwent surgical procedures for bilateral symmetric strabismus from January 18, 2000, through November 16, 2001, were recruited. One eye was randomized to receive topical 1% rimexolone while the contralateral eye received topical 0.1% fluorometholone, 4 times daily for 4 weeks.

Main outcome measures: Intraocular pressures and anti-inflammatory responses were the main outcome measures and were serially measured postoperatively for 8 weeks.

Results: Fifty-four children, aged from 4 to 8 years (mean [SD] age, 5.33 [1.26] years), participated in the study. Intraocular pressure increased significantly in both treatment groups compared with the preoperative values (P<.001). The mean (SD) peak intraocular pressure was significantly higher in the rimexolone-treated group, 19.7 (6.1) vs 17.6 (4.6) mm Hg (P<.001). Similarly, the mean (SD) net increase in intraocular pressure (P<.001), was also higher in the rimexolone-treated eyes, 5.9 (4.4) vs 3.9 (4.1) mm Hg (P<.001). In addition, a greater percentage of the rimexolone-treated patients had no conjunctival erythema on days 13 (11.1% vs 0.0%) and 20 (88.9% vs 55.6%) (P =.03).

Conclusions: Rimexolone seems to be a more effective anti-inflammatory agent than fluorometholone. However, unlike adults, the ocular-hypertensive effect in children treated with rimexolone was higher. It would be desirable to monitor the intraocular pressure regularly when rimexolone therapy is used in children.

Publication types

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

MeSH terms

  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / adverse effects*
  • Child
  • Child, Preschool
  • Cross-Over Studies
  • Double-Blind Method
  • Female
  • Fluorometholone / administration & dosage
  • Fluorometholone / adverse effects
  • Glucocorticoids / administration & dosage
  • Glucocorticoids / adverse effects*
  • Humans
  • Inflammation / drug therapy
  • Intraocular Pressure / drug effects*
  • Male
  • Ocular Hypertension / chemically induced*
  • Ophthalmic Solutions
  • Pregnadienes / administration & dosage
  • Pregnadienes / adverse effects*
  • Strabismus / surgery

Substances

  • Anti-Inflammatory Agents
  • Glucocorticoids
  • Ophthalmic Solutions
  • Pregnadienes
  • rimexolone
  • Fluorometholone