Clinical evaluation of ketorolac tromethamine 0.5% ophthalmic solution for the treatment of seasonal allergic conjunctivitis

Surv Ophthalmol. 1993 Jul-Aug:38 Suppl:141-8. doi: 10.1016/0039-6257(93)90038-9.

Abstract

We evaluated 148 patients with allergic conjunctivitis in a double-masked, paired comparison clinical trial comparing ketorolac 0.5% ophthalmic solution with vehicle. Patients received one drop of each study medication in preassigned eyes, four times a day, for seven days. Both treatments showed significant changes from baseline in the signs and symptoms associated with allergic conjunctivitis. Evaluations at the final visit (day 7 or 8) showed that ketorolac-treated eyes had a significant treatment response when compared to vehicle-treated eyes for conjunctival inflammation (p = 0.010), ocular itching (p = 0.006), swollen eyes (p = 0.002), discharge/tearing (p = 0.021), foreign body sensation (p = 0.035), and conjunctival injection (p = 0.016). Mean scores evaluating the overall therapeutic effect of the study treatments at the completion of the study were higher for ketorolac-treated eyes than for vehicle-treated eyes as rated by investigators (p = 0.004) and study patients (p < 0.001). Results of this study confirmed the trends of a previous study showing that ketorolac 0.5% ophthalmic solution applied topically is an effective therapy for allergic conjunctivitis.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Conjunctivitis, Allergic / drug therapy*
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Combinations
  • Drug Evaluation
  • Female
  • Humans
  • Ketorolac Tromethamine
  • Male
  • Middle Aged
  • Ophthalmic Solutions
  • Pharmaceutical Vehicles
  • Tolmetin / administration & dosage
  • Tolmetin / adverse effects
  • Tolmetin / analogs & derivatives*
  • Tromethamine / administration & dosage*
  • Tromethamine / adverse effects

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Drug Combinations
  • Ophthalmic Solutions
  • Pharmaceutical Vehicles
  • Tromethamine
  • Ketorolac Tromethamine
  • Tolmetin