Efectividad e impacto en la calidad de vida del colirio de ketotifeno: Resultados del estudio ZETA en pacientes con conjuntivitis alérgica estacional

Merayo, J; Montero, J; Sainz de la Maza, MT; Fuster, E; Lladonosa, A

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Archivos de la Sociedad Española de Oftalmología

Print version ISSN 0365-6691

Abstract

MERAYO, J et al. Effectiveness and impact in the quality of life of ketotifen ophthalmic solution: Results of ZETA study in patients with seasonal allergic conjunctivitis. Arch Soc Esp Oftalmol [online]. 2003, vol.78, n.8, pp.433-441. ISSN 0365-6691.

Purpose: To study the effectiveness of ketotifen ophthalmic solution (0.25 mg/ml) in seasonal allergic conjunctivitis (SAC) and the impact on the patients 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 questionnaire of quality of life (QOL) pre-treatment and minimum one week after initiating the 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) decreased significantly. Comparing both QOL, we observed a statistically significant reduction of the limitation perceived by the patients in their daily activities, animic state and ocular symptoms. In 0,7% some adverse event was referred, none was serious and only in one case the probable relationship with the drug was specified. Conclusion: 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.

Keywords : Ketotifen ophthalmic solution; seasonal allergic conjunctivitis (SAC); effectiveness; tolerability; quality of life.

· abstract in Spanish · text in Spanish