This is an international, multicentre, randomised, parallel group, investigator-masked study of 554 patients, having insufficient control of intraocular pressure (IOP) with a first-line monotherapy and requiring dual therapy. Two hundred and eighty patients were randomised to receive low concentration (BTFCEG group) and 274 received higher concentration (BTFCED group). The primary endpoint was the change in IOP from baseline to week 12 at 8:00 in the assessed eye. Secondary outcomes were further efficacy and safety endpoints. The mean +/- SD change in IOP from baseline to 12 week at 8:00 was -10.96 +/-3.43mmHg for the BTFCEG group and -11.14 +/-3.56mmHg for the BTFCED group. IOP-lowering efficacy was shown at all other timepoints. The safety profile was comparable between the treatment groups. No patients in the BTFCEG group discontinued the study due to treatment-related adverse events compared with 8 (2.9%) patients in the BTFCED group. The authors conclude that low-concentration BTFCEG can be considered as a safe and effective therapeutic treatment of glaucoma and ocular hypertension.

