Comparison of Latanoprost and Timolol in Pediatric Glaucoma: A Phase 3, 12-Week, Randomized, Double-Masked Multicenter Study
Abstrakt
Objective: To compare the efficacy and safety of latanoprost versus timolol in pediatric patients with glaucoma. Design: Prospective, randomized, double-masked, 12-week, multicenter study.
Participants: Individuals aged -3 mmHg. A proportion of responders (subjects with >= 15% IOP reduction at weeks 4 and 12) were evaluated.
Analyses were performed in diagnosis subgroups: primary congenital glaucoma (PCG) and non-PCG. Results: In total, 137 subjects were treated (safety population; 12-18 years, n=48; 3-<12 years, n=55; 0-<3 years, n=34).
Mean age was 8.8 +/- 5.5 years, and mean baseline IOP was 27.7 +/- 6.17 mmHg; 125 subjects completed the study, and 107 subjects were in the per protocol population. Mean IOP reductions for latanoprost and timolol at week 12 were 7.2 and 5.7 mmHg, respectively, with a difference of 1.5 mmHg (95% CI, -0.8 to 3.7; P=0.21).Responder rates were 60% for latanoprost and 52% for timolol (P=0.33).
Between-treatment differences in mean IOP reduction for PCG and non-PCG subgroups were 0.6 mmHg (95% CI, -2.3 to 3.4) and 2.6 mmHg (95% CI, -0.8 to 6.1), respectively. Responder rates for latanoprost versus timolol were 50% versus 46% for the PCG group and 72% versus 57% for the non-PCG group.
Both therapies were well tolerated. Conclusions: Latanoprost 0.005% is not inferior (i.e., is either more or similarly effective) to timolol and produces clinically relevant IOP reductions across pediatric patients with and without PCG.
Both latanoprost and timolol had favorable safety profiles over the duration of this 3-month trial.