Double-masked, paired-comparison clinical study of ketorolac tromethamine 0.5% ophthalmic solution compared with placebo eyedrops in the treatment of seasonal allergic conjunctivitis.

In a multicenter, double-masked, clinical study, we compared the ocular safety and efficacy of ketorolac 0.5% ophthalmic solution with placebo in alleviating the signs and symptoms of allergic conjunctivitis. The study was conducted in 93 patients who received one drop of the appropriate treatments in each eye, four times a day, for seven days. Of these subjects, 74 were evaluated for efficacy. The principal clinical sign of allergic conjunctivitis, conjunctival inflammation, and six allergic symptoms (itching, swollen eyes, burning or stinging, discharge or tearing, foreign body sensation, and photophobia) were evaluated by the investigators at midweek (day 3 or 4) and at the end of the study (day 7 or 8). Ketorolac was superior to placebo in reducing conjunctival inflammation (p = 0.003) and itching (p = 0.020), the principal clinical symptom, at the final examination. In addition, ketorolac was favored over placebo in reducing the other five symptoms evaluated. On the day of final examination, overall therapeutic response evaluated by the investigators rated ketorolac as superior to placebo (p = 0.007). A significant placebo effect was noted in this study, as has been previously reported in clinical studies of allergic conjunctivitis patients. Results of this study demonstrate that 0.5% ketorolac ophthalmic solution used topically four times daily, for seven days, was effective in alleviating the principal sign and the symptoms associated with allergic conjunctivitis.