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To examine the safety, efficacy, and tolerability of a novel Bilastine 0.6% preservative-free eye-drops compared to Ketotifen (antihistamine) 0.025% for the symptomatic relief of allergic conjunctivitis.
The use of Bilastine 0.6% eye drops without preservatives can provide immediate relief and have the advantage of once daily in patients with allergic conjunctivitis. It has superior comfort and tolerability on instillation.
To examine the safety, efficacy, and tolerability of a novel Bilastine 0.6% preservative-free eye-drops compared to Ketotifen (antihistamine) 0.025% for the symptomatic relief of allergic conjunctivitis.
In this phase 3 randomized study, Bilastine 0.6% ophthalmic solution efficacy was compared with Ketotifen 0.025% and vehicle control. Reduction in ocular itching was the key efficacy endpoint. The ocular and nasal symptoms at 15 minutes (onset of action) and 16 hours after the therapy was examined with the help of the Ora-CAC® Allergen Challenge Model. This model is sanctioned by regulatory agencies to decide upon the therapeutic efficacy in alleviating allergic symptoms.
Out of the total 228 people, 59.6% were men and the mean age was 44.1 years. Bilastine was found to relieve ocular itching compared to vehicle at the given time points (Figure 1):
In comparison with the vehicle control, Ketotifen displayed improvement after 15 minutes of the therapy. Given the inferiority margin of 0.4, Bilastine exhibited statistical non-inferiority to Ketotifen for all three defined time points at 15 minutes after the instillation of the eye drops.
In comparison with the vehicle control, Bilastine improved conjunctival, ciliary and episcleral redness, eye irritation, swelling in the eyelids, tearing, runny nose, ear and palate itching and stuffy nose (congestion) after 15 minutes of use.
There were no safety concerns found to be linked to Bilastine use. It had significantly better mean drop comfort scores compared with Ketotifen instantly upon instilling the eye drop solution and was similar to vehicle control.
Ophthalmic Bilastine is a safe, effective, and well-tolerated therapy for easing the signs and symptoms of allergic conjunctivitis.
Journal of Investigational Allergology and Clinical Immunology
Bilastine 0.6% preservative-free eye drops, a once-daily treatment for allergic conjunctivitis
Gomes PJ et al.
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