Merayo J ; Montero J ; Sainz De La Maza MT; Fuster E; Lladonosa A: IOBA (Instituto Universitario de Oftalmología Aplicada), Valladolid, Spain; Servicio de Oftalmología, Hospital Universitario Virgen de la Macarena, Seville, Spain; Servicio de Oftalmología,Hospital Clínico y Provincial, Barcelona, Spain; Novartis Farmacéutica, Barcelona, Spain; Biométrica, Barcelona, Spain. Arch Soc Esp Oftalmol 2003; 78: 433-442. PURPOSE: To study the effectiveness of ketotifen ophthalmic solution (0.25 mg/ml) in seasonal allergic conjunctivitis (SAC) and the impact on the patient's quality of life.
METHODS: A multicentric, longitudinal, prospective study was designed. 284 Spanish ophthalmologists participated recruiting 1145 patients with SAC. After obtaining the informed consent, a drop of ketotifen ophthalmic solution was instilled. At the visit, clinical symptoms pre and post-treatment were assessed. The patients answered a quality of life (QOL) pre-treatment and minimum one week after initiating treatment. The qualitative variables were described by the percentage, and the quantitative were described by the average, median, standard deviation and maximum and minimum values. The effectiveness (change of intensity of the symptoms) and the quality of life were studied by the Wilcoxon test with a significance level of 5% ( α = 0.05).
RESULTS: Following the instillation of the ketotifen ophthalmic solution the intensity of the ocular symptoms (redness, edema, tearing, secretion, photophobia and visual acuity impairment) decresed significantly. Comparing both QOL, we observed a statistically significant reduction of the limitation perceived by the patients in their daily activities, mental state and ocular symptoms. In 0.7% some adverse event was referred, none was serious and anly in one case was the probable relationship with the drug was specified.
CONCLUSIONS: The results of the ZETA study demonstrate the tolerability and effectiveness of the ketotifen ophthalmic solution for all the symptoms of SAC in clinical practice, observing improvement in the quality of life of the patient.
Zaditen®(ketotifen) 0.025% eye drops were well tolerated and effective in relieving the signs and symptoms of allergic conjunctivitis, and significantly improved the patients' quality of life.