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                                                         Efficacy of DTFC compared with the BTFC
                                                         AGP Konstas et al
                                                                                                       83



                                                Patients screened (n=77)
                                                                Excluded (n=7)
                                                                Not meeting
                                                                inclusion criteria (n=3)
                                                                Refused to participate
                                                                (n=4)
                                                  Timolol run-in period
                                                     (n=70)
                                                               Excluded (n=5)
                                                                IOP < 18 mmHg (n=3)
                                                                IOP reduction < 20%
                                                                (n=2)
                                                  Randomized (n=65)




                                      DTFC (n=32)                 BTFC (n=33)
                                    Withdrawals (n=2)  Treatment period 1   Withdrawals (n=3)


                                     BTFC (n=30)  Treatment period 2  DTFC (n=30)




                                                Total completed trial (n=60)

             Figure 1 Flow diagram of patients enrolled in study.

             Table 2 Comparison of IOP levels (mm Hg)
                                   Untreated (95% CI)  Diurnal timolol (95% CI)  24-h DTFC (95% CI)  24-h BTFC (95% CI)
             Mean                   27.9 (27.2, 28.7) a  20.9 (20.4, 21.4) b  18.0 (17.5, 18.6) c  18.7 (18.1, 19.4) c
             Mean adjusted difference   F           �6.9 (�7.4, �6.4) b  �9.9 (�10.6, �9.2) c  �9.2 (�9.9, �8.5) c
             from untreated                            Po0.001          Po0.001         Po0.001
             Mean adjusted difference   F                F           �2.9 (�3.4, �2.5) c  �2.2 (�2.8, �1.7) c
             from diurnal timolol                                       Po0.001         Po0.001
             Mean 24-h adjusted difference  F            F           �0.7 (�1.0, �0.3) c  F
                                                                        Po0.001
             Abbreviations: BTFC, brimonidine/timolol-fixed combination; CI, confidence interval; DTFC, dorzolamide/timolol-fixed combination.
             a Adjusted for site.
             b Adjusted for site and untreated IOP.
             c Adjusted for site and timolol run-in period.

             The peak and minimum 24-h IOP were, however,  P ¼ 0.012, respectively). Conversely, more patients
             significantly lower with DTFC compared with BTFC  experienced conjuctival hyperaemia with BTFC
             (P ¼ 0.003 and P ¼ 0.033, respectively). These results were  compared with DTFC (16.7 vs 5.0%, P ¼ 0.039). There
             similar when the per-protocol analysis was performed.  were no significant differences in the other adverse
                                                         events between the two fixed combination treatment
                                                         groups (see Table 4).
             Adverse events
             No serious adverse event concerns were identified
                                                         Discussion
             during this study. Patients treated with DTFC
             experienced bitter taste (18.3%) and stinging (16.7%)  Fixed combination therapy in glaucoma has gained
             more often than when treated with BTFC (P ¼ 0.001 and  popularity in recent years, presumably because of the



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