This 5-year, randomized, open-label safety study «Goldberg I, Li XY, Selaru P ym. A 5-year, randomiz...»1 compared once-daily latanoprost with usual care, defined as any commercially available IOP-reducing medication except latanoprost. The study was conducted at 406 centers in 14 countries. Patients were excluded if they had previously been or currently were being treated with latanoprost or another prostaglandin. In all, 5893 patients were randomized, and 5854 (99.3 %) received at least one dose of study medication.
The first subject visit occurred 1999, and the last was on 2005. In the total safety population, 3936 (67.2 %) patients were randomized to latanoprost, and 2707/3936 (68.8 %) completed the study; 1918 patients were initially randomized to usual care, and 1285/1918 (67.0 %) completed the study. At baseline, approximately 95 % of patients were receiving IOP-reducing medications, with 78 % being treated with ß-adrenergic antagonists and 20 % receiving topical carbonic anhydrase inhibitors.
Among patients ever treated with latanoprost, investigators judged that 577/4638 (12.4 %) had increased iris pigmentation compared to those who used any other IOP reducing agent, 1871/4638 (40.3 %) experienced eyelash changes, and 363/4638 (7.8 %) had increased pigmentation of the periorbital skin.
In the total safety population, the 5-year incidence of macular edema, iritis/uveitiss, or corneal erosions was low and (≤ 2.72 %) and comparable for patients randomized to latanoprost or usual care ; latanoprost vs. usual care 2.41 %/1.88 %, incidence of iritis/uveitis 2.49 %/2.24 %, incidence of corneal erosions 2.72 %/2.19 %. Kaplan-Meyer estimates indicated a low risk (≤ 3.17) for each of three events at 5 years. Rates of these events in the total latanoprost and initial treatment populations were consistent with those for the total safety population.
Denis (2010) conducted an open label uncontrolled 3-month study of once-daily use of 0.005 percent latanoprost in 258 ophthalmology practices that included 600 participants with OHT or OAG «Denis P, Baudouin C, Bron A ym. First-line latanop...»2. Keratitis was reported in 0.8 % of patients.