Affiliation:
1. Helmholtz National Medical Research Center of Eye Diseases
Abstract
Purpose: a comparative study of the efficacy and safety of the combination drug Brinzopt Plus and the original drug Azarga used as adjunctive therapy in patients with primary open-angle glaucoma (POAG) previously treated with latanoprost.Material and methods. 30 patients (42 eyes) with advanced and far advanced POAG were randomly divided into 2 groups of equal size. The patients of the main group (21 eyes) received Brinzopt Plus, those of the control group had the original drug Azarga, one instillation 2 times a day. The target points were intraocular pressure (IOP), visual acuity, perimetric indices (MD, PSD), mean retinal nerve fiber layer thickness, minimal neuroretinal rim width, retinal nerve fiber layer thickness in the macula, ganglion cell layer thickness in the macula, inner plexiform layer thickness, as well as the number of adverse events. The observation period was 12 weeks. IOP was measured at 4 and 12 weeks.Results. After 2 weeks, both groups showed a statistically significant decrease in IOP, which remained stable after 4 and 12 weeks. The average decrease in IOP in Brinzopt Plus recipients was 25% and revealed no statistically significant differences with the original drug at any control point. A positive dynamic of visual acuity, static perimetry and optical coherence tomography values, which showed no significant intergroup differences, was recorded. Among the adverse events, manifestations of mild local discomfort were recorded in 4 out of 15 patients of the main group and in 3 out of 15 patients of the control group. No serious or systemic adverse events were noted.Conclusion. Brinzopt Plus has an efficacy comparable to the original drug and a favorable safety profile.
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