Comparative study of the ocular efficacy and safety of diclofenac sodium (0.1%) ophthalmic solution with that of ketorolac tromethamine (0.5%) ophthalmic solution in patients with acute seasonal allergic conjunctivitis.

BACKGROUND: Seasonal allergic conjunctivitis (SAC) is the most common and most prevalent of allergic disorders which afflict the ocular surface. Of the several treatments available, ophthalmic non-steroidal anti-inflammatory drugs, are generally very safe and tolerable.

AIM: The aim of this study is to compare the ocular efficacy and safety of diclofenac sodium (0.1%) ophthalmic solution with that of ketorolac tromethamine (0.5%) ophthalmic solution in patients with acute SAC.

MATERIALS AND METHODS: Sixty patients with signs and symptoms of SAC were evaluated in an open, randomized, parallel group study. The principle symptoms (ocular itching, burning, discharge, photophobia) and signs (ocular inflammation, lid edema, chemosis, conjunctival mucous, keratitis) were evaluated.

STUDY DESIGN: Patients were randomized into two groups of 30 each. Patients in group A received one drop of diclofenac sodium 0.1% and patients in group B received ketorolac tromethamine 0.5% in both the eyes four times a day for fourteen days. Evaluations were performed at day 0, 3, 7 and 14 of the therapy. At each visit, the signs and symptoms were rated using a scale from 0-3 (mild-1, moderate-2 and severe-3).

RESULTS: Significant clinical and statistical reductions in signs and symptoms from baseline were observed in both groups. Diclofenac sodium 0.1% was superior to ketorolac tromethamine 0.5% in reducing ocular itching (P < 0.05) and ocular inflammation (P < 0.05), at the final examination.

CONCLUSION: Diclofenac sodium showed statistically significant better results at day 3 and 7 compared to ketorolac.