IntroductionGlaucoma patients frequently exhibit ocular surface side effects during treatment with prostaglandin eye drops. The present work investigated whether glaucoma patients suffering from signs and symptoms of ocular surface disease while using preserved latanoprost eye drops benefited from switching to preservative-free tafluprost eye drops.Patients and methodsThe analysis was based on 339 glaucoma patients enrolled in two Phase IIIb trials. The patients were required to have two symptoms, or one sign and one symptom of ocular surface disease at baseline, and at least 6 months preceding treatment with latanoprost eye drops preserved with benzalkonium chloride. All eligible patients were switched from latanoprost to preservative-free tafluprost for a total of 12 weeks. Ocular symptoms and ocular signs were evaluated at baseline and at 2 weeks, 6 weeks, and 12 weeks after commencing treatment with tafluprost. Intraocular pressure (IOP), drop discomfort, and treatment preference were evaluated to investigate the clinical efficacy and patient-related outcomes.ResultsAfter 12 weeks of treatment with preservative-free tafluprost, the incidences of irritation/burning/stinging, foreign body sensation, tearing, itching, and dry eye sensation had diminished to one-third of those reported for preserved latanoprost at baseline. The incidences of blepharitis and corneal/conjunctival fluorescein staining had in turn decreased to one-half of those reported for preserved latanoprost. Severity of conjunctival hyperemia was halved during treatment with preservative-free tafluprost, and there was significant improvement in tear break-up time and tear production. A further reduction in IOP (~1 mmHg) was seen with preservative-free tafluprost compared with preserved latanoprost. Drop discomfort was alleviated during preservative-free tafluprost treatment, and an outstanding majority of patients (72%) preferred preservative-free tafluprost over preserved latanoprost.ConclusionThis meta-analysis confirmed that IOP remained at the same level after replacing benzalkonium chloride-preserved latanoprost eye drops with preservative-free tafluprost eye drops. Preservative-free tafluprost significantly decreased the symptoms and signs of ocular surface disease and outrated latanoprost in drop comfort and treatment preference.
IntroductionThis article presents the results of an international, multicenter, randomized, double-masked, placebo-controlled clinical study of Visomitin (Mitotech LLC, Moscow, Russian Federation) eye drops in patients with dry eye syndrome (DES). Visomitin is the first registered (in Russia) drug with a mitochondria-targeted antioxidant (SkQ1) as the active ingredient.MethodsIn this multicenter (10 sites) study of 240 subjects with DES, study drug (Visomitin or placebo) was self-administered three times daily (TID) for 6 weeks, followed by a 6-week follow-up period. Seven in-office study visits occurred every 2 weeks during both the treatment and follow-up periods. Efficacy measures included Schirmer’s test, tear break-up time, fluorescein staining, meniscus height, and visual acuity. Safety measures included adverse events, slit lamp biomicroscopy, tonometry, blood pressure, and heart rate. Tolerability was also evaluated.ResultsThis clinical study showed the effectiveness of Visomitin eye drops in the treatment of signs and symptoms of DES compared with placebo. The study showed that a 6-week course of TID topical instillation of Visomitin significantly improved the functional state of the cornea; Visomitin increased tear film stability and reduced corneal damage. Significant reduction of dry eye symptoms (such as dryness, burning, grittiness, and blurred vision) was also observed.ConclusionBased on the results of this study, Visomitin is effective and safe for use in eye patients with DES for protection from corneal damage.FundingMitotech LLC.
Purpose: Beta‐blockers and prostanoid F2α (PF2α) analogues reduce intraocular pressure (IOP) by complementary mechanisms. A combination of treatments with additive effects may be beneficial to further reduce IOP in patients not sufficiently controlled with a single agent. This study aimed to investigate the efficacy and safety of tafluprost, a new PF2α derivative in development, as adjunctive therapy to timolol.
Methods: In this multi‐national, multi‐centre, parallel‐group, double‐masked, phase III study, 185 patients with open‐angle glaucoma or ocular hypertension and with IOP between 22‐30 mmHg on timolol, were randomised to tafluprost 0.0015% eye drops (n=96) or vehicle (n=89) as adjunctive therapy with timolol 0.5% eye drops for 6 weeks. The primary endpoint was change from baseline in the overall diurnal IOP at 6 weeks. Safety parameters were also analysed.
Results: At week 6, the additional effect of tafluprost, as compared to timolol baseline, was between 22‐24%. This additional effect was consistently larger than in the vehicle group. There were more ocular events, including conjunctival redness, iris colour and eyelash changes with tafluprost compared with the vehicle (overall 42% vs 29%), but most were mild in severity.
Conclusions: Tafluprost, when administered as adjunctive therapy to timolol, is effective and well tolerated for the treatment of glaucoma and ocular hypertension.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.