European journal of ophthalmology · 2009
Xal-Ease: impact of an ocular hypotensive delivery device on ease of eyedrop administration, patient compliance, and satisfaction.
Сравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Nordmann Jean-Philippe, Baudouin Christophe, Bron Alain, Denis Philippe, Rouland Jean-Francois, Sellem Eric, Renard Jean-Paul
Аннотация
PURPOSE: To measure the impact of the Xal-Ease delivery device on ease of eyedrop administration and on treatment compliance and satisfaction.
METHODS: This prospective, multicenter, randomized, comparative, crossover study was conducted at 43 sites in France. Eligible subjects were >18 years of age, were diagnosed with primary open-angle glaucoma or ocular hypertension, had been treated with latanoprost or fixed-combination latanoprost/timolol for >or=3 months prior to enrollment, and did not require a therapy change. Subjects used either Xal-Ease or the dropper bottle for 4 weeks and then switched to the alternate delivery method for the next 4 weeks. Subjects completed questionnaires after 1 and 4 weeks in each treatment period.
RESULTS: In all, 211 subjects were enrolled, 107 to the Xal-Ease/dropper bottle group and 104 to the dropper bottle/Xal-Ease group. Baseline demographic and ocular characteristics were similar. Use of Xal-Ease made it significantly less likely that the subject would need someone to help with drop instillation (6.9% vs 18.1%, respectively; p<0.001) and reduced the problem of the tip of the bottle touching the eye (3.2% vs 35.6%, respectively; p<0.001). Reported compliance rates were very high and similar across groups during both treatment periods. After 1 month of use during both treatment periods, more than 70% of subjects reported global satisfaction with Xal-Ease to their physicians. No adverse events associated with the use of Xal-Ease were noted.
CONCLUSIONS: Xal-Ease generally makes administration of latanoprost or fixed-combination latanoprost/timolol easier compared with the dropper bottle.
METHODS: This prospective, multicenter, randomized, comparative, crossover study was conducted at 43 sites in France. Eligible subjects were >18 years of age, were diagnosed with primary open-angle glaucoma or ocular hypertension, had been treated with latanoprost or fixed-combination latanoprost/timolol for >or=3 months prior to enrollment, and did not require a therapy change. Subjects used either Xal-Ease or the dropper bottle for 4 weeks and then switched to the alternate delivery method for the next 4 weeks. Subjects completed questionnaires after 1 and 4 weeks in each treatment period.
RESULTS: In all, 211 subjects were enrolled, 107 to the Xal-Ease/dropper bottle group and 104 to the dropper bottle/Xal-Ease group. Baseline demographic and ocular characteristics were similar. Use of Xal-Ease made it significantly less likely that the subject would need someone to help with drop instillation (6.9% vs 18.1%, respectively; p<0.001) and reduced the problem of the tip of the bottle touching the eye (3.2% vs 35.6%, respectively; p<0.001). Reported compliance rates were very high and similar across groups during both treatment periods. After 1 month of use during both treatment periods, more than 70% of subjects reported global satisfaction with Xal-Ease to their physicians. No adverse events associated with the use of Xal-Ease were noted.
CONCLUSIONS: Xal-Ease generally makes administration of latanoprost or fixed-combination latanoprost/timolol easier compared with the dropper bottle.
Предметные рубрики MeSH
AgedAntihypertensive AgentsCross-Over StudiesDrug Delivery SystemsDrug Therapy, CombinationFemaleGlaucoma, Open-AngleHumansLatanoprostMaleMiddle AgedOcular HypertensionOphthalmic SolutionsPatient CompliancePatient SatisfactionProspective StudiesProstaglandins F, SyntheticSurveys and QuestionnairesTimolol