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L. M. Baiza-Duran, R. Varma, Krytantek Ofteno Study Group; Six Month Safety and Efficacy of a New Fixed Combination of Timolol-Brimonidine-Dorzolamide Compared to a Fixed Combination of Timolol-Dorzolamide. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2478.
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To evaluate the 6 month safety and efficacy of a new fixed combination of 0.5% timolol, 0.2% brimonidine and 2% dorzolamide in ophthalmic solution versus 0.5% timolol and 2% dorzolamide fixed combination in the treatment of patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
We conducted a multicenter, double masked, randomized clinical trial.in patients with a diagnosis of OAG or OHT, with intraocular pressures (IOPs) ranging between 21 and 31mm Hg were included in the study. Patients were randomized to 2 groups - one was treated with a new fixed dose formulation of timolol-brimonidine-dorzolamide (Krytantek Ofteno®, Laboratorios Sophia, Mexico - KO) and the second was treated with timolol-dorzolamide fixed combination (Cosopt®, MSD Laboratories, USA - CO). Patients received 1 drop twice a day of either formulations and were examined on days 2, 7, 15, 30, 60, and 90, 120, 150 and 180 after initiation of treatment. The primary outcome measure was change in IOP from baseline at the 180 day follow-upvisit. Safety parameters evaluated were: Visual Acuity, visual fields, conjunctival hyperemia and corneal surface staining with Rose Bengal and fluorescein dye. Patient reported measures (PRO) such as pain, burning sensation, photophobia and foreign body sensation were also assessed.
A total of 112 patients were enrolled in the trial - 56 patients in each of the two groups. 7 patients (4 in CO group and 3 in KO group) did not complete the study. The mean baseline IOP was 24.1±2.6mmHg in the KO group, and 23.6±2.2mmHg in CO group (p=0.28). The mean IOP change from baseline at each of the study visits was significantly greater in the KO group compared to the CO group. At the 180 day follow-up visit, the mean IOP change from baseline was significantly greater in the KO group (9.90 ± 2.95mmHg) compared to the CO group (6.8 ± 3.42mmHg)(p<0.001). Furthermore, at the 180 day visit, a decrease in IOP from baseline of 7mm Hg or more was present in 94% (50/53) of patients in the KO group compared to 62% (32/52) in the CO group (p<0.001). No differences in the safety and PRO measures were noted between the two groups.
In this randomized controlled trial, through 6 months of follow-up, KO was more effective in reducing the IOP than CO. This new fixed combination allows for the simplification of a multi-drug regimen by reducing the total number of drops instilled per day and may improve adherence to chronic therapy.
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