J T Przydryga1, C Egloff. 1. Alcon Laboratories, Inc., Fort Worth, Texas--USA. Johan.Przydryga@AlconLabs.com
Abstract
PURPOSE: To assess the intraocular pressure lowering effect of travoprost 0.004% in patients previously treated with another topical medication, and in previously untreated patients. METHODS: This 12-week, open-label trial in 1590 patients was conducted at 219 sites in Switzerland. Primary open-angle glaucoma and ocular hypertension patients discontinued prior medications, and instilled 1 drop of travoprost in each affected eye at 8 pm. Untreated patients were subdivided into 2 groups: baseline IOP of > or = 21 mmHg, and baseline IOP of < or = 20 mmHg. Patients returned for follow-up visits at 1 and 3 months. The primary outcome was mean IOP change from baseline to follow-up. RESULTS: Of 626 patients previously on monotherapy, and525 previously untreated or newly-diagnosed patients, 479 and 423, respectively, completed 3 months of therapy. The mean changes from baseline at 1 month (mmHg +/- SD), by prior treatment group were: beta blocker, -4.9 (+/- 3.6); latanoprost, -2.3 (+/- 2.8); alpha-agonist, -4.0 (+/- 3.7); dorzolamide/timolol fixed combination, -3.4 (+/- 3.9); topical CAI, -4.4 (+/- 3.1); new IOP > or = 21 mmHg, -8.6 (+/- 4.4); new IOP < or = 20 mmHg, -4.4 (+/- 3.0). (All changes from baseline were statistically significant (p < 0.0001). CONCLUSIONS: In patients previously treated with a single drug, travoprost decreased IOP to pressures below those achieved on prior therapy. In all groups, travoprost reduced mean IOP below 18 mmHg within 1 month of starting therapy, and control was maintained for at least 3 months. Overall, travoprost was safe and well-tolerated.
RCT Entities:
PURPOSE: To assess the intraocular pressure lowering effect of travoprost 0.004% in patients previously treated with another topical medication, and in previously untreated patients. METHODS: This 12-week, open-label trial in 1590 patients was conducted at 219 sites in Switzerland. Primary open-angle glaucoma and ocular hypertensionpatients discontinued prior medications, and instilled 1 drop of travoprost in each affected eye at 8 pm. Untreated patients were subdivided into 2 groups: baseline IOP of > or = 21 mmHg, and baseline IOP of < or = 20 mmHg. Patients returned for follow-up visits at 1 and 3 months. The primary outcome was mean IOP change from baseline to follow-up. RESULTS: Of 626 patients previously on monotherapy, and 525 previously untreated or newly-diagnosed patients, 479 and 423, respectively, completed 3 months of therapy. The mean changes from baseline at 1 month (mmHg +/- SD), by prior treatment group were: beta blocker, -4.9 (+/- 3.6); latanoprost, -2.3 (+/- 2.8); alpha-agonist, -4.0 (+/- 3.7); dorzolamide/timolol fixed combination, -3.4 (+/- 3.9); topical CAI, -4.4 (+/- 3.1); new IOP > or = 21 mmHg, -8.6 (+/- 4.4); new IOP < or = 20 mmHg, -4.4 (+/- 3.0). (All changes from baseline were statistically significant (p < 0.0001). CONCLUSIONS: In patients previously treated with a single drug, travoprost decreased IOP to pressures below those achieved on prior therapy. In all groups, travoprost reduced mean IOP below 18 mmHg within 1 month of starting therapy, and control was maintained for at least 3 months. Overall, travoprost was safe and well-tolerated.