Bilastine 0.6% ophthalmic solution (6 mg/mL) was presented in sterile, preserved solution in ampoules for single use (FAES FARMA S.A., Leioa, Spain). Placebo was the vehicle, with same presentation. Bilastine ophthalmic solution and placebo were identical in color and appearance. The packaging and labelling did not allow for any distinction between test and reference drug. One drop of bilastine or placebo was instilled in each eye once daily in the morning (one ampoule for both eyes). On the days of Visit 2a, Visit 3a and Visit 4a, this was done by a medically qualified person onsite. On the other days, the patient administered one drop in each eye once daily. The duration of treatment for the individual patient was 56 days. The complete study duration (including screening and follow-up) was 70 days. Each patient had to document daily the administration of the ophthalmic solutions in an e-diary.
Prior and concomitant treatment with the following medication and therapies was prohibited: anti-allergy immunotherapy, corticosteroid treatment, depot-corticosteroids, any ophthalmic agents (including artificial tears), systemic or intranasal treatment for allergic rhinitis (ie, antihistamines, mast cell stabilizers, or leukotriene inhibitors).
Prior and concomitant treatment with the following medication and therapies was prohibited: anti-allergy immunotherapy, corticosteroid treatment, depot-corticosteroids, any ophthalmic agents (including artificial tears), systemic or intranasal treatment for allergic rhinitis (ie, antihistamines, mast cell stabilizers, or leukotriene inhibitors).
