Background: This study was designed to determine the efficacy and safety of latanoprost 50 micrograms/ml in Chinese patients with primary open-angle glaucoma (POAG) and ocular hypertension (OH).
Methods: A 14-day randomized, double-masked, parallel-group study comparing topical latanoprost with placebo was followed by a 10-week, one-armed, open-labeled latanoprost treatment study. Intraocular pressure (IOP), visual function, ocular manifestations and miscellaneous adverse effects were evaluated at baseline, and days 1, 7, 14, 15, week 6 and week 12 visits.
Results: Twenty-six eligible patients were enrolled in the study. The mean IOP was significantly reduced from baseline only in the latanoprost-treated eyes during the first study period (p = 0.003 on day 1; p = 0.004 on day 7; p < 0.001 on day 14). Meanwhile, the mean IOP was significantly lower in the latanoprost-treated eyes than that in the placebo-treated eyes (p = 0.03 on day 1; p = 0.001 on days 7 and 14). Eyes in both groups showed significantly reduced IOP at each visit of the secondary 10-week latanoprost treatment period, with a mean decrease of 6.12 mmHg. The IOP-lowering effect showed no diminution throughout the study course. Conjunctival hyperemia occurred in 16 of all patients who underwent latanoprost treatment and was the most frequent adverse effect observed. No patient withdrew from the study because of intolerable side-effects.
Conclusions: Topical latanoprost is effective in reducing IOP for patients with POAG and OH. The pressure-lowering effect lasts for at least 24 hours after 1 drop instillation and no drift of effect is noted during this 12-week study. Conjunctival hyperemia was the most common side-effect, which was mild in degree and recovered after discontinuation of the medication.