INTRODUCTION:Patients with glaucoma or ocular hypertension who do not achieve target intraocular pressure (IOP) using one hypotensive agent are often transitioned to combination therapy. Travoprost 0.004%/timolol 0.5% fixed combination (TTFC) has shown efficacy in patients whose IOP is not controlled with other therapies. The goal of this study was to assess the efficacy and safety of transitioning to TTFC in patients whose IOP was uncontrolled on bimatoprost 0.03%/timolol 0.5%, administered concomitantly or as a fixed combination. METHODS: This was a prospective, open-label, multicenter study of patients with open-angle glaucoma or ocular hypertension who transitioned to TTFC from fixed or unfixed bimatoprost/timolol. Patients self-administered TTFC once daily for 8 weeks, and efficacy and safety were assessed at baseline, Week 4, and Week 8. A symptom survey was administered at baseline and Week 8. Both patients and investigators reported their medication preference at Week 8. RESULTS:A total of 105 patients were enrolled in the study. Mean IOP decreased by 16.5% from baseline after 8 weeks of TTFC therapy in the total population, 15.0% in patients transitioning from fixed-combination therapy, and 20.8% in patients transitioning from unfixed therapy (P<0.001 for all groups). The percentage of patients reaching target IOP (≤18 mmHg) after treatment with TTFC was 69.2% (P<0.001). Patients judged stinging/burning to be less severe with TTFC than with prior therapy (P=0.029); all other symptom frequencies and severities were similar for both treatments. Patients preferred TTFC over bimatoprost/timolol (fixed and unfixed) at a ratio of more than 4:1 (81.4% vs. 18.6%; P<0.001), and investigators reported a nearly five-fold preference for TTFC (83.3% vs. 16.7%; P<0.001). No unexpected safety concerns with TTFC were observed. CONCLUSION: Travoprost 0.004%/timolol 0.5% fixed combination produced a significant reduction in IOP, with favorable safety and tolerability profiles. Both patients and investigators strongly preferred TTFC to prior bimatoprost 0.03%/timolol 0.5% therapy.
RCT Entities:
INTRODUCTION:Patients with glaucoma or ocular hypertension who do not achieve target intraocular pressure (IOP) using one hypotensive agent are often transitioned to combination therapy. Travoprost 0.004%/timolol 0.5% fixed combination (TTFC) has shown efficacy in patients whose IOP is not controlled with other therapies. The goal of this study was to assess the efficacy and safety of transitioning to TTFC in patients whose IOP was uncontrolled on bimatoprost 0.03%/timolol 0.5%, administered concomitantly or as a fixed combination. METHODS: This was a prospective, open-label, multicenter study of patients with open-angle glaucoma or ocular hypertension who transitioned to TTFC from fixed or unfixed bimatoprost/timolol. Patients self-administered TTFC once daily for 8 weeks, and efficacy and safety were assessed at baseline, Week 4, and Week 8. A symptom survey was administered at baseline and Week 8. Both patients and investigators reported their medication preference at Week 8. RESULTS: A total of 105 patients were enrolled in the study. Mean IOP decreased by 16.5% from baseline after 8 weeks of TTFC therapy in the total population, 15.0% in patients transitioning from fixed-combination therapy, and 20.8% in patients transitioning from unfixed therapy (P<0.001 for all groups). The percentage of patients reaching target IOP (≤18 mmHg) after treatment with TTFC was 69.2% (P<0.001). Patients judged stinging/burning to be less severe with TTFC than with prior therapy (P=0.029); all other symptom frequencies and severities were similar for both treatments. Patients preferred TTFC over bimatoprost/timolol (fixed and unfixed) at a ratio of more than 4:1 (81.4% vs. 18.6%; P<0.001), and investigators reported a nearly five-fold preference for TTFC (83.3% vs. 16.7%; P<0.001). No unexpected safety concerns with TTFC were observed. CONCLUSION:Travoprost 0.004%/timolol 0.5% fixed combination produced a significant reduction in IOP, with favorable safety and tolerability profiles. Both patients and investigators strongly preferred TTFC to prior bimatoprost 0.03%/timolol 0.5% therapy.