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OBJECTIVE: The aim was to evaluate the efficacy of Optive Plus(®), an artificial tear containing castor oil, in patients with dry eye, in a routine clinical setting. METHODS: This was a prospective, noninterventional study of patients with dry eye who switched from a prior therapy or who were naïve to treatment (n=1,209). Patients were issued Optive Plus(®) artificial tears. Dry eye severity, tear break-up time (TBUT), Schirmer score, Ocular Surface Disease Index (OSDI) score, and patient assessment of symptoms were recorded at baseline and at the follow-up visit (4 weeks after starting Optive Plus(®)). RESULTS: The cause of dry eye was determined to be aqueous deficiency, lipid deficiency, or a mixture of aqueous and lipid deficiency (in 19.5%, 20.1%, and 47.8%, respectively, of the total study population). The severity of dry eye decreased from baseline to the follow-up visit, showing a decrease of the more severe levels (2-4) and a concurrent increase in mild level (1) of the rating scale. Patients reported an improvement in dry eye symptoms over the duration of the study, specifically 74.2% (n=152), 85.4% (n=182), and 82.4% (n=417) of patients in the aqueous-deficient, lipid-deficient, and mixed-deficiency groups, respectively. TBUT was measured in 475 patients. Baseline measurements for mean and standard deviation were 9.0±3.5, 7.1±3.6, and 6.6±3.0 seconds for the aqueous-deficient, lipid-deficient, and mixed-deficiency groups, respectively. These increased to 10.5±3.5, 10.0±3.6, and 9.2±3.1 seconds at the final visit. Overall, 92.5% of all patients were satisfied with the use of Optive Plus(®), and 86% said they would purchase Optive Plus(®). Ten percent of patients reported adverse events, and 1.8% of all patients experienced treatment-related adverse events. CONCLUSION: Optive Plus(®) was well tolerated and effective in reducing the signs and symptoms of all types of dry eye but is recommended for lipid-deficient dry eye patients.
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OBJECTIVE: To compare a fixed combination of 0.03% bimatoprost and 0.5% timolol (BTFC) with latanoprost monotherapy (LM) in treatment-naïve patients with open-angle glaucoma (OAG) and risk factors for glaucomatous progression. METHODS: Patients were enrolled at 15 sites in Spain and Portugal, and were randomized 1:1 to BTFC or LM. Patients instilled one drop of medication once per day at 8 pm for 12 weeks. The primary outcome was change in intraocular pressure (IOP) at 12 weeks. RESULTS: Of 81 patients enrolled, 43 were randomized to BTFC and 38 to LM. Mean (SD) change in IOP from baseline to 12 weeks was significantly greater for BTFC than for LM: -13.5 mmHg (4.48) versus -11.4 mmHg (3.19), respectively (P=0.003). Similarly, at 12 weeks, significantly more BTFC patients than LM patients had IOP reductions of ≥40% (74.4% versus 47.4%, P=0.015) or ≥50% (46.5% versus 15.8%, P=0.003). Adverse events were more frequent with BTFC than with LM (33 versus 13 events), but most were mild in severity. The only serious adverse event (colon cancer) was adjudged unrelated to the study medication. CONCLUSION: BTFC was effective and well tolerated in treatment-naïve patients with OAG at high risk of progression.
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OBJECTIVE: The aim of this study was to evaluate the safety and efficacy of a fixed combination of bimatoprost 0.03% and timolol (BTFC) in a clinical setting, in a large sample of patients with primary open-angle glaucoma or ocular hypertension and insufficient intraocular pressure (IOP) lowering on prior therapy. METHODS: Patient data were combined (n = 5556) from five multicenter, observational, non-controlled, open-label studies throughout Europe. Patients were identified from 830 sites in Austria, France, Germany, The Netherlands, and Switzerland. Assessments were made at baseline, 6 weeks (in Austrian, German and Swiss centers), and 12 weeks in all centers. RESULTS: BTFC lowered mean IOP from baseline by 5.4 mmHg over the 12-week duration of the studies (P < 0.0001). At study entry, 92.9% of patients were receiving another ocular hypotensive medication. In patients with no previous treatment (n = 311), BTFC reduced IOP by -9.1 mmHg, corresponding to a reduction from baseline of 36.4% (P < 0.0001). In patients receiving prior therapy of a prostaglandin analog, a ß-blocker, or a fixed combination, BTFC reduced IOP by a further 24.5%, 25.9%, and 21.4%, respectively. The majority of patients (90.3%) reported no adverse events. The most common adverse events were conjunctival hyperemia (3.2%) and eye irritation (2.8%). BTFC was rated as "good" or "very good" by 92.5% of physicians and 88.0% of patients. Most patients (96.3%) were equally or more compliant with BTFC than with their previous treatment. CONCLUSION: In routine clinical practice, BTFC achieved consistent IOP lowering in both previously treated and untreated patients with primary open-angle glaucoma or ocular hypertension. BTFC was associated with significant IOP reductions, good tolerability, and good compliance.
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The distribution of prion infectivity and PrPSc between peripheral lymphoid tissues suggests their possible haematogenic spread during the progression of natural scrapie in susceptible sheep. Since ovine PBMCs (peripheral blood mononuclear cells) express PrPC, they have the potential to carry or harbour disease-associated forms of PrP. To detect the possible presence of disease-associated PrP on the surface of blood cells, an understanding is required of the conformations that normal ovine cell-surface PrPC may adopt. In the present study, we have used monoclonal antibodies that recognize epitopes in either the N- or C-terminal portions of PrP to probe the conformations of PrPC on ovine PBMCs by flow cytometry. Although PBMCs from scrapie-susceptible and -resistant genotypes of sheep expressed similar levels of cell-surface PrPC, as judged by their reactivity with N-terminal-specific anti-PrP monoclonal antibodies, there was considerable genotypic heterogeneity in the region between helix-1 and residue 171. Cells from PrP-VRQ (V136R154Q171) sheep showed uniform reactivity with monoclonal antibodies that bound to epitopes around helix-1, whereas cells from PrP-ARQ (A136R154Q171) and PrP-ARR (A136R154R171) sheep showed variable binding. The region between b-strand-2 and residue 171, which includes a YYR motif, was buried or obscured in cell-surface PrPC on PBMCs from scrapie-susceptible and -resistant sheep. However, an epitope of PrPC that is influenced by residue 171 was more exposed on PBMCs from PrP-VRQ sheep than on PBMCs from the PrP-ARQ genotype. Our results highlight conformational variation between scrapie-susceptible and -resistant forms of cell-surface PrPC and also between allelic variants of susceptible genotypes.
