OBJECTIVE: To investigate the influence of switching to travoprost on intraocular pressure (IOP) of chronic open-angle glaucoma (COAG) patients. RESEARCH DESIGN AND METHODS: Multicentre, open-label, non-comparative, 12-week, phase IV study conducted at 10 academic and hospital centres in Hungary. Patients' compliance to use of the pre-study medication was confirmed at a visit 10 days before the baseline measurements, and compliance was monitored throughout the study period. RESULTS: Of the 203 COAG patients three (1.48%) ceased travoprost medication due to ocular hyperaemia, and one subject was lost from follow-up. Self-reported compliance was optimal except for two patients. For the per-protocol analysis 197 patients were evaluable. IOP of the 37 per-protocol patients receiving additional travoprost medication decreased from 23.1 +/- 3.2 mmHg (mean +/- SD) to 17.3 +/- 2.6 mmHg at week 12 (p < 0.001). Switching the 121 per-protocol patients from latanoprost to travoprost IOP decrease from 20.8 +/- 3.5 mmHg to 17.7 +/- 2.4 mmHg (p < 0.001). IOP of the 11 patients switched from topical nonselective beta-blockers to travoprost decreased from 20.1 +/- 2.1 mmHg to 15.7 +/- 1.5 mmHg (p < 0.001). For the whole per-protocol population (n = 197) IOP decreased from 21.0 +/- 3.4 mmHg to 17.4 +/- 2.4 mmHg (p < 0.001). Defining responders as having an IOP decrease > 2.0 mmHg or >or= 5 mmHg at week 12, the responder rate was respectively 62.9% or 31% for the total study population; 86.5% or 54.1% when travoprost was added to the established therapy; 54.5% or 24.0% if latanoprost was switched to travoprost; and 90.9% or 36.4% for those who switched from beta-blockers. CONCLUSION: Travoprost provided a clinically and statistically significant IOP decrease in uncontrolled COAG patients whose self-reported compliance to their previous topical medication was optimal. Our results suggest that the IOP reduction found after switching to travoprost is not explainable by improved compliance due to the clinical study situation.
OBJECTIVE: To investigate the influence of switching to travoprost on intraocular pressure (IOP) of chronic open-angle glaucoma (COAG) patients. RESEARCH DESIGN AND METHODS: Multicentre, open-label, non-comparative, 12-week, phase IV study conducted at 10 academic and hospital centres in Hungary. Patients' compliance to use of the pre-study medication was confirmed at a visit 10 days before the baseline measurements, and compliance was monitored throughout the study period. RESULTS: Of the 203 COAG patients three (1.48%) ceased travoprost medication due to ocular hyperaemia, and one subject was lost from follow-up. Self-reported compliance was optimal except for two patients. For the per-protocol analysis 197 patients were evaluable. IOP of the 37 per-protocol patients receiving additional travoprost medication decreased from 23.1 +/- 3.2 mmHg (mean +/- SD) to 17.3 +/- 2.6 mmHg at week 12 (p < 0.001). Switching the 121 per-protocol patients from latanoprost to travoprost IOP decrease from 20.8 +/- 3.5 mmHg to 17.7 +/- 2.4 mmHg (p < 0.001). IOP of the 11 patients switched from topical nonselective beta-blockers to travoprost decreased from 20.1 +/- 2.1 mmHg to 15.7 +/- 1.5 mmHg (p < 0.001). For the whole per-protocol population (n = 197) IOP decreased from 21.0 +/- 3.4 mmHg to 17.4 +/- 2.4 mmHg (p < 0.001). Defining responders as having an IOP decrease > 2.0 mmHg or >or= 5 mmHg at week 12, the responder rate was respectively 62.9% or 31% for the total study population; 86.5% or 54.1% when travoprost was added to the established therapy; 54.5% or 24.0% if latanoprost was switched to travoprost; and 90.9% or 36.4% for those who switched from beta-blockers. CONCLUSION:Travoprost provided a clinically and statistically significant IOP decrease in uncontrolled COAG patients whose self-reported compliance to their previous topical medication was optimal. Our results suggest that the IOP reduction found after switching to travoprost is not explainable by improved compliance due to the clinical study situation.