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First Author: R.Altafini ITALY
Co Author(s): M. Scherzer A. Ogundele P. Frezzotti
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To compare the patient preference for Brinzolamide 1.0%/Timolol 0.5% eye drops versus Dorzolamide 2.0%/Timolol 0.5% eye drops after 7 days of twice daily (BID) dosing of each treatment in patients with open-angle glaucoma (OAG) or ocular hypertension (OH).
11 centers (4 Italy, 5 Germany; 2 United Kingdom)
This was a single-masked, crossover study design. Patients were randomized 1:1 to self-administer (except for Day 7 am dose) one drop of either Brinzolamide 1.0%/Timolol 0.5% or Dorzolamide 2.0%/Timolol 0.5% in both eyes BID for 7 days. Following a 48-hour washout period, on Day 9 patients crossed-over to opposite treatment (self-administered except for Day 15 am dose). After completion of each treatment period, patients completed an ocular discomfort scale (scores ranging 0 to 9) to assess the level of ocular comfort experienced. The primary endpoint was patient preference for treatment based on ocular comfort assessed using a subject questionnaire administered on Day 15. The questionnaire consisted of a single preference question rating preference for 1st medication or 2nd medication.
Enrolled patients in the intent-to-treat dataset (N= 108) had a mean age of 66.3 years, of which most were predominantly female (63.9%). Following completion of both treatment periods, significantly more patients (60.2%, 65/108) preferred Brinzolamide 1.0%/Timolol 0.5% to Dorzolamide 2.0%/Timolol 0.5% (95% CI 0.51, 0.70, p=0.0428). Mean level of ocular discomfort was less with Brinzolamide 1.0%/Timolol 0.5% compared to Dorzolamide 2.0%/Timolol 0.5% (2.6 versus 3.7, P<0.0002). No serious adverse events were reported. A total of 15 patients (9 on Brinzolamide 1.0%/Timolol 0.5% and 6 on Dorzolamide 2.0%/Timolol 0.5%) experienced at least 1 treatment-related adverse event.
Patient preference for Brinzolamide 1.0%/Timolol 0.5% was higher than for Dorzolamide 2.0%/Timolol 0.5% in patients with either open-angle glaucoma or ocular hypertension.
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