Abstract
Purpose:
To prospectively evaluate and compare the intraocular pressure (IOP) reduction efficacy and safety between bimatoprost (Bim) and latanoprost (Lat)-timolol-fixed combination (LTFC) in Japanese open-angle glaucoma patients.
Methods:
This study involved 62 eyes of 62 Japanese open-angle glaucoma patients (37 females and 25 males, mean age: 66.9±13.3 years) who had used Lat monotherapy for more than 4 weeks, and randomly divided them into two groups; 1) Bim group and 2) LTFC group. Both groups were switched from Lat to Bim or LTFC for 12 weeks. Written informed consent was obtained from all patients. IOP, conjunctival injection score (grade 0-3), corneal epitheliopathy score (area density classification; AD score), and tear film break-up time (BUT) were evaluated at 0, 4, and 12 weeks post switching, respectively. If both eyes were available, right-eye data was used. The Paired t-test and Mann Whitney U test were used for statistical analysis.
Results:
Of the 62 patients, 49 were analyzed for IOP reduction and safety and 13 dropped out of the study. At 0, 4, and 12 weeks, mean IOP of the Bim group (26 eyes) and LTFC group (23 eyes) were 13.2, 11.5, and 11.6 mmHg, and 13.4, 11.7, and 11.5 mmHg, respectively. In both groups, the mean IOP had already significantly decreased at 4 weeks compared with week 0 (P<0.0001 in both groups). Comparisons between the two groups showed no significant differences. The conjunctival injection scores were 0.6±0.5 at baseline, and 1.1±0.8 (Bim group) and 0.6±.0.5 (LTFC group) at 12 weeks. The conjunctival injection score at 12 weeks was higher in the Bim group than in LFTC group (P=0.0171). The corneal AD scores (total score of area and density grade) were 1.6±1.5 at baseline, and 1.7±1.4 (Bim group) and 1.7±1.4 (LTFC group) at 12 weeks, and BUT was 6.0±4.2 seconds (sec) at baseline, and 5.8±4.4 sec (Bim group) and 5.4±4.0 sec (LTFC group) at 12 weeks. There were no significant differences between the two drugs in relation to AD score and BUT.
Conclusions:
The finds of this study show that Bim and LTFC have equal efficacy for the reduction of IOP. Safety comparisons between the two drugs showed that only the conjunctival injection score at 12 weeks was higher in the Bim group than in the LFTC group.
Keywords: 466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials