[Multicenter double-blind study with 0.25% timolol in Gelrite (TG) once daily vs. 0.25% timolol solution (TS) twice daily. German Study Group].

In a 12-week double-masked trial we compared the ocular hypotensive effect of 0.25% timolol in Gelrite administered once daily (TG) to that of 0.25% timolol solution administered twice daily (TS). A second objective was to compare the tolerability and the safety of these treatments. Timolol in Gelrite is a new topical formulation of timolol in an anionic heteropolysaccharide gellan gum. A total of 156 patients entered the study after an appropriate wash-out. The medication schedule included one drop of test drug in each eye at 9 a.m. (active drug for both groups) and 9 p.m. (placebo for the TG group, active drug for the TS group). At trough, the mean decrease from baseline intraocular pressure (after appropriate wash-out) ranged from 5.7 to 6.3 mmHg for the TG group and from 5.9 to 6.2 mmHg for the TS group. The difference between the treatment group means ranged from -0.4 to 0.4 mmHg. At peak, the mean decrease from baseline IOP ranged from 5.3 to 6.2 mmHg for TG group and from 5.1 to 6.1 mmHg for the TS group. The difference between the treatment group means ranged from -0.7 to 0.4 mmHg. The results of this study support the hypothesis of a comparable hypotensive effect at peak and trough of 0.25% timolol in Gelrite q.d. to 0.25% timolol solution b.i.d. Furthermore, timolol in Gelrite has an acceptable tolerability profile. The incidence of blurred vision was higher in the Gelrite group, but this different was not statistically significant. The incidence of foreign body sensation was significantly higher in the Gelrite group (P < 0.022).(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes