Abstract
BackgroundA noninferiority trial was conducted to evaluate the efficacy of a single evening dose of fixed-combination latanoprost 50 μg/mL and timolol 0.5 mg/mL (Xalacom®; LTFC), in Chinese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH) who were insufficiently controlled on β-blocker monotherapy or β-blocker-based dual therapy.MethodsThis 8-week, randomized, open-label, parallel-group, noninferiority study compared once-daily evening dosing of LTFC with the unfixed combination of latanoprost, one drop in the evening, and timolol, one drop in the morning (LTuFC). The primary efficacy endpoint was the mean change from baseline to week 8 in diurnal intraocular pressure (IOP; mean of 8 AM, 10 AM, 2 PM, 4 PM IOPs). LTFC was considered noninferior to LTuFC if the upper limit of the 95% confidence interval (CI) of the difference was < 1.5 mmHg (analysis of covariance).ResultsBaseline characteristics were similar for LTFC (N = 125; POAG, 70%; mean IOP, 25.8 mmHg) and LTuFC (N = 125; POAG, 69%; mean IOP, 26.0 mmHg). Mean diurnal IOP changes from baseline to week 8 were -8.6 mmHg with LTFC and -8.9 mmHg with LTuFC (between-treatment difference: 0.3 mmHg; 95%-CI, -0.3 to 1.0). Both treatments were well tolerated.ConclusionsA single evening dose of LTFC was at least as effective as the unfixed combination of latanoprost in the PM and timolol in the AM in reducing IOP in Chinese subjects with POAG or OH whose IOP was insufficiently reduced with β-blocker monotherapy or β-blocker-based dual therapy. LTFC is an effective and well tolerated once-daily treatment for POAG and OH.Trial registrationClinicaltrials.gov registration: NCT00219596
Highlights
A noninferiority trial was conducted to evaluate the efficacy of a single evening dose of fixedcombination latanoprost 50 μg/mL and timolol 0.5 mg/mL (Xalacom®; LTFC), in Chinese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH) who were insufficiently controlled on b-blocker monotherapy or b-blocker-based dual therapy
At the baseline visit after washout, intraocular pressure (IOP) measured at 10 AM was required to be ≥21 and ≤35 mmHg and ≥25% higher than the IOP level at screening in at least 1 eye for b-blocker monotherapy users, or ≥21 and ≤35 mmHg and ≥30% higher than the IOP at screening in at least 1 eye for those treated with b-blocker-based dual therapy
With the exception of a somewhat greater proportion of females in the LTFC group (53% vs. 40%, respectively), treatment groups were similar with regard to age, diagnosis, mean baseline IOP, and prior ocular hypotensive medication
Summary
A noninferiority trial was conducted to evaluate the efficacy of a single evening dose of fixedcombination latanoprost 50 μg/mL and timolol 0.5 mg/mL (Xalacom®; LTFC), in Chinese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH) who were insufficiently controlled on b-blocker monotherapy or b-blocker-based dual therapy. Primary open-angle glaucoma (POAG) in Chinese individuals over the age of 40 years has an estimated prevalence of approximately 1.5% to. Timolol generally is well tolerated, a significant proportion of timolol-treated patients does not achieve targeted IOP levels [6], and approximately one-third require a change in or addition to initial timolol monotherapy after 1 year, a proportion that increases to one-half after 2 years [7]
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