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Comparison of the therapeutic efficacy of 0.1% olopatadine hydrochloride and 0.025% ketotifen fumarate in allergic conjunctivitis

Shah-Jalal Sarker, Abu Nayeem Chowdhury, Zahid Hussain, AKM Mosharrof Hossain and Hashem Chowdhury

Aims: To study whether 0.1% olopatadine hydrochloride (OHCL) is more effective and safer than 0.025% ketotifen fumarate (KF) in the management of allergic conjunctivitis. Methods: 83 patients with the sign (hyperemia) and symptoms of allergic conjunctivitis (i.e., tearing, itching and photophobia) were randomized (stratifying by age and sex) 1:1 to receive either 0.1% OHCL or 0.025% KF (one drop in each eye every 12 h). Signs and symptoms were scored before and after 2 weeks of drug therapy using a fourpoint scale (range: 0–3) while side effects were scored 30 min and 2 weeks after treatment initiation. A composite score of signs and symptoms was defined by adding all measures of signs and symptoms and then subtracting the week 2 sum from the pretreatment sum. Results: Both drugs reduced signs and symptoms of allergic conjunctivitis at 2 weeks from baseline. The treatment with 0.1% OHCL was more effective compared with 0.025% KF, as the mean (SD) composite score of 6.3 (±1.3) for the OHCL group was significantly higher than that of 4.3 (±1.7) for the KF group (p < 0.001, two-sided t-test). KF reduced the mean scores of hyperemia, tearing, itching and photophobia by 64, 63, 55 and 81%, respectively, while OHCL reduced these by 96, 97, 88 and 96%. Relative significant efficacy was achieved for hyperemia, tearing and itching (p ≤ 0.001) but not for photophobia (p = 0.315). No adverse events were observed in the OHCL group while 30% of patients in the KF group showed mild stinging or foreign body sensation after instillation of the first dose. Conclusion: 0.1% OHCl is more effective and safer (in the short term) than 0.025% KF in the management of allergic conjunctivitis.