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JR Hazelton, JT Whitson, C Henry, S Terry, B Hughes, DA Lee; Comparison of the Intraocular Pressure Effect and Safety of Dorzolamide 2% Versus Brimonidine 0.2%, Each Given Three Times Daily for Six Weeks in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension . Invest. Ophthalmol. Vis. Sci. 2002;43(13):4098.
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Purpose: To compare the IOP effect of dorzolamide 2% TID (D) versus brimonidine 0.2% TID (B) in POAG or OHTN patients. Methods: In a multi-center, prospective, double-masked, crossover comparison, 39 POAG or OHTN patients were studied. After initial washout, patients proceeded through two six-week treatment periods, randomized to either D or B first. Treatments were separated by a four-week washout. Change (baseline to end of the treatment) in IOP at trough was the primary efficacy variable. Tolerability was also assessed. Analysis involved a comparative assessment of treatment periods, using a two-sided t-test. Sub-analysis included percent achievement of 15% reduction at trough and percentage of patients who had lower pressure on either D or B. Results: Of the 39 patients enrolled, 35 completed period 1, and 30 both treatment periods. Patient characteristics: 16 male 23 female, and mean age of 61. Sixty-five treatment periods were analyzed: 33 D and 32 B. Baseline IOP was similar for both groups: 24.06 mmHg for D and 24.26 mmHg for B (p=.84). Both groups achieved a statistically significant reduction in trough: D was -3.07 mmHg (-11%)(p<.001) and B was -2.77 mmHg (-10%)(p=.0017). Between group difference was not statistically significant (p=.75). Percent of patients who achieved 15% reduction from baseline at trough was 45% for D and 34% for B (P=.51). Of the 30 patients completing both treatment periods, 55% on D had lower IOP than on B (p=.60)(NS). Side effects were minimal and as expected for both agents. Changes in BP, HR, and VA were minimal and not different between groups. Of statistical significance, stinging was 54% of B and 21% of D (P=.017). Conclusion: D and B as monotherapy appeared effective in IOP reductions at trough, despite a higher incidence of 15% IOP reduction with D. Stinging was observed as more prevalent observed with B.
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