Abstract
Purpose: :
Elevated intraocular pressure (IOP) is a major risk factor for open angle glaucoma. To evaluate the effectiveness and safety of Cosopt® alone or co–administered with XalatanTM in the management of elevated IOP in patients with open angle glaucoma (OAG) and ocular hypertension (OH). Multicenter, open–label, 12–week prospective cohort, observational study of 254 patients recruited across Canada. Patients with either OAG or OH whose IOP remained uncontrolled after a 4 week treatment with XalatanTM were recruited and Cosopt® was added. Those who did not respond at all to XalatanTM therapy (< 15% IOP reduction) were switched to Cosopt®.
Results: :
243 patients completed the study. Mean (SD) age was 68 (12) and 56% were female. Risk factors reported were hypertension (n=134, 55.1%), family history of open angle glaucoma (n=84, 34.6%), myopia (n=74, 30.5%), and diabetes mellitus (n=35, 14.4%). 196 (80.7%) were treated with Cosopt® in combination with XalatanTM and 47 (19.3%) were treated with Cosopt® alone. Mean (SD) IOP decreased from 22.34 (4.79) mmHg at baseline to 15.78 (3.82) mmHg in the combination Cosopt®–XalatanTM group and from 23.14 (4.92) mmHg to 17.29 (3.17) mmHg in the Cosopt® group when measured at peak. Both groups had clinically and statistically significant IOP reductions (P<0.001). There were 150 (92.6%) patients who achieved the target IOP reduction of at least an additional 10% from baseline. Reasons for withdrawal were adverse events (n=5, 1.9%), consent withdrawal (n=2, 0.8%), lack of efficacy (n=1, 0.4%) and protocol violation (n=1, 0.4%). There were 56 adverse events related to the study treatment of which 43 were mild, 8 were moderate and 5 were severe. The most frequently reported adverse events were eye irritation (n=19, 7.8%) and burning sensation (n=7, 2.9%).
Conclusions: :
Cosopt® alone or co–administered with XalatanTM provides effective reduction of IOP, and is well tolerated in this population of patients with IOP uncontrolled by XalatanTM.
Keywords: intraocular pressure • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • pharmacology