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M. Iizuka, C. Birt, D. Yan; Xalacom Fixed Combination versus Timoptic XE and Xalatan Unfixed Combination: A Study of Effectiveness and Safety in the Treatment of Open Angle Glaucoma and Ocular Hypertension . Invest. Ophthalmol. Vis. Sci. 2005;46(13):2460.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: The purpose of this study was to compare the intraocular pressure–lowering efficacy of XalacomTM fixed–combination therapy (FC) to XalatanTM combined with Timoptic XETM 0.5% unfixed combination (UFC) in the treatment of chronic open angle glaucoma or ocular hypertension. The secondary objective was to compare compliance, safety and patient satisfaction between the two regimens. Methods: This was a single masked randomized controlled trial. Patients with open angle glaucoma or ocular hypertension controlled on Xalatan qHS and Timoptic XE 0.5% qAM were randomized to either continue their current therapy (UFC, n=25) or to switch to Xalacom qHS (FC, n=24). Intraocular pressure was measured between 10:00h and 12:00h at baseline, 4 weeks and 12 weeks. A questionnaire about side effects, compliance and patient satisfaction was administered at week 12. Results: Baseline IOP was not statistically different (p = 0.81) between the UFC group (15.4 +/– 2.8mmHg) and the FC group (15.5+/–3.2mmHg). For the UFC group, the IOP did not significantly change from baseline to week 4 (15.7+/–2.8mmHg, p=0.46) or week 12 (15.5+/–2.8mmHg, p=0.94). For the FC group, there was a weakly significant increase in IOP at week 4 (16.2+/–3.5mmHg, p=0.04) but not at week 12 (16.2+/–3.9mmHg, p = 0.11). Compliance and side effect profiles in both groups were similar based on patient questionnaires. Almost all patients on Xalacom (23 out of 24 patients) preferred using a single bottle over the two bottle regimen of Timoptic XE and Xalatan that they were using prior to entering the study. Conclusions: The IOP did not significantly change throughout the duration of the study in the patient group remaining on the unfixed combination of Xalatan and Timoptic XE. However, in the patient group that switched to Xalacom, there was a weakly significant increase of 0.7 mmHg in IOP at week 4, though a similar increase in IOP only showed a trend towards statistical significance at week 12. Patients randomized to Xalacom expressed a preference for using only one bottle over the two bottle regimen.
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