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Naka Shiratori,1,2 Yusuke Nishio,1,2 Ayaka Takeda,1,2 Shio Sugimoto,1,2 Kenji Takazawa,2 Naomi Otsuka,3 Naruhiro Ishida,3 Daisuke Shii,3 Kiyotaka Hori,3 Kenji Nakamoto1 1Department of Ophthalmology, Nippon Medical School, Tokyo, Japan; 2Shinanozaka Clinic, Tokyo, Japan; 3Japan Medical Affairs Group, Santen Pharmaceutical Co. Ltd., Osaka, JapanCorrespondence: Naka ShiratoriDepartment of Ophthalmology, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, JapanTel +81-3-3822-2131Fax +81-3-5685-0988Email shiratori@nms.ac.jpPurpose: To clarify the intraocular pressure (IOP)-lowering effect of a selective prostanoid EP2 receptor agonist, omidenepag isopropyl (OMDI) during a 24-hour period.Patients and Methods: Subjects aged ≥ 20 years and with diagnosed, untreated primary open-angle glaucoma or ocular hypertension were enrolled. IOP measurements were performed every 4 hours over a 24-hour period using a Goldmann applanation tonometer (GAT) and Icare PRO tonometer (PRO). The baseline 24-hour IOP was measured in untreated subjects. After the baseline measurements, participants were given OMDI 1 drop once daily at night for 4 weeks. At week 4, the IOP measurement was repeated under the same conditions. Diurnal (9 am, 1 pm, 5 pm) and nocturnal (9 pm, 1 am, 5 am) IOP measurements were compared between baseline and treatment with OMDI. Safety measures included adverse events, slit-lamp biomicroscopy, visual acuity, heart rate and blood pressure.Results: Of 27 participants enrolled, 25 patients (20 males and 5 females, average age 52.2 ± 8.5 years) completed the study. In the sitting position, the baseline diurnal and nocturnal mean IOPs (GAT) were 19.1 ± 2.1 mmHg and 18.2 ± 2.6 mmHg, respectively, the diurnal and nocturnal mean IOP reduction from baseline were – 2.8 ± 2.6 mmHg (p < 0.0001) and – 3.3 ± 2.9 mmHg (p < 0.0001), respectively, mean 24-hour IOP (GAT) was significantly lower with the OMDI treatment (− 3.1 ± 2.5 mmHg, p < 0.0001). In the supine position, the baseline nocturnal mean IOP (PRO) was 17.99 ± 2.22 mmHg, and the nocturnal mean IOP reduction from baseline was − 1.78 ± 2.37 mmHg (p = 0.0009) after 4 weeks of the treatment. Nine adverse events were observed in 8 patients including mild conjunctival hyperemia (n = 8) and mild iritis (n=1). There were no significant effects on systemic safety.Conclusion: Once daily OMDI treatment was able to produce stable 24-hour IOP reduction.Keywords: omidenepag isopropyl, prostanoid EP2 agonist, 24-hour IOP control

Koji Nitta,1,2 Gaku Tachibana,1,2 Ryotaro Wajima,1,2 Sachie Inoue,3 Tatsuya Ohigashi,4 Naomi Otsuka,4 Hiroaki Kurashima,4 Kazunori Santo,4 Masayo Hashimoto,4 Hidetoshi Shibahara,3 Mai Hirukawa,3 Kazuhisa Sugiyama2 1Department of Ophthalmology, Fukui-Ken Saiseikai Hospital, Fukui, Japan; 2Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan; 3CRECON Medical Assessment Inc., Tokyo, Japan; 4Japan Medical Affairs Group, Santen Pharmaceutical Co., Ltd., Osaka, JapanCorrespondence: Koji Nitta Email nitta.koji7001@fukui.saiseikai.or.jpPurpose: To maintain visual fields and quality of life over a lifetime, medical practice must be conducted taking into consideration not only visual field progression but also future visual field changes that occur over the patients’ expected lifespan. The purpose of this study is to investigate the feasibility of establishing a model that predicts prognosis, estimating the proportion of glaucoma patients with severe visual field defects.Patients and Methods: The data of 191 patients with primary open-angle glaucoma, with a predominance of normal-tension glaucoma, were used for this study. The model was developed based on patients’ backgrounds and risk factors, using Monte Carlo simulation. A “severe visual field defect” was defined as ≤-20 dB. The mean deviation (MD) value for 10,000 virtual patients in each simulation pattern (144 patterns) was calculated using a predictive formula to estimate the MD slope, and the effects of risk factors and intraocular pressure (IOP) reduction on the proportion of patients with severe visual field defects were evaluated.Results: Younger age, later-stage disease, more severe glaucomatous structural abnormalities and the presence of disc hemorrhage were associated with an increase in the progression rate of patients with severe visual field defects. Conversely, lower IOP was associated with a decrease in this rate.Conclusion: Combining regression analysis with Monte Carlo simulation could be a useful method for developing predictive models of prognosis in glaucoma patients.Keywords: glaucoma, epidemiology, prognosis, risk factors, simulation

Kenji Nakamoto,1 Masahiko Takeshi,2 Toshihiko Hiraoka,2,3 Mayuko Eguchi,2,4 Yuichiro Nakano,1,2 Naomi Otsuka,5 Hiroko Hizaki,5 Hiromi Akai,5 Masayo Hashimoto5 1Department of Ophthalmology, Nippon Medical School, Tokyo, Japan; 2Shinanozaka Clinic, Tokyo, Japan; 3Hiraoka Eye Clinic, Saitama, Japan; 4Musashiurawa Eye Clinic, Saitama, Japan; 5Japan Medical Affairs, Global R&D, Santen Pharmaceutical Co., Ltd., Osaka, Japan Objective: The aim of this study was to evaluate the 24-hour intraocular pressure (IOP)-control effect of the tafluprost/timolol fixed combination (TAF/TIM-FC) in patients with primary open-angle glaucoma after they switched from the concomitant use of tafluprost and timolol gel-forming solution. Patients and methods: Twenty patients with primary open-angle glaucoma (12 male and 8 female; mean ± SD age, 57.0±7.1 years) were included in this study. The patients were treated for 8 weeks with the concomitant administration of tafluprost and timolol gel-forming solution (evening dosing). At the end of this period, the patients underwent 24-hour IOP monitoring (measured at 21:00, 01:00, 05:00, 09:00, 13:00 and 17:00). IOP was measured with Goldmann applanation tonometer (GAT) and Icare PRO at sitting position at all timepoints and additionally, at supine position with Icare PRO tonometer at 01:00 and 05:00. The patients were then all switched to TAF/TIM-FC treatment (evening dosing). After 8 weeks, the 24-hour IOP monitoring was repeated. Results: Nineteen patients completed the study. The mean 24-hour IOPs in the concomitant and TAF/TIM-FC phases were 13.8±2.7 vs 13.3±2.8 mmHg (P=0.0033) with the GAT in the sitting position and 13.96±2.56 vs 13.48±2.56 mmHg (P=0.0120) with the Icare PRO in habitual positions. In comparison with the concomitant phase, significantly lower IOP was observed for the TAF/TIM-FC phase at 21:00 and 01:00 with the GAT and at 01:00 with the Icare PRO. In addition, the maximum IOP and fluctuations in IOP in habitual positions were lower for the TAF/TIM-FC phase than for the concomitant phase. Conclusion: TAF/TIM-FC showed a stable 24-hour IOP-lowering effect and was equally or more effective than the concomitant use of tafluprost and timolol gel, both when sitting and when in habitual positions. Keywords: intraocular pressure, tafluprost, circadian IOP, 24-hour IOP, timolol gel

Ikuko Yataba,1 Noboru Otsuka,1 Isao Matsushita,1 Hideo Matsumoto,2 Yuichi Hoshino3 1Taisho Pharmaceutical Co, Ltd, 2Institute for Integrated Sports Medicine, School of Medicine, Keio University, Tokyo, 3Department of Orthopedics Surgery, School of Medicine, Jichi Medical University, Tochigi, Japan Background: Nonsteroidal anti-inflammatory drug (NSAID) patches are convenient for use and show much less gastrointestinal side effects than oral NSAIDs, whereas its percutaneous absorption is not sufficient for the expression of clinical efficacy at satisfactory level. S-flurbiprofen plaster (SFPP) has shown dramatic improvement in percutaneous absorption results from animal and clinical studies. In this study, the efficacy and safety of SFPP were compared with placebo in patients with knee osteoarthritis (OA) to determine its optimal dose. This was a multicenter, randomized, double-blind, parallel-group comparative study. Patients and methods: Enrolled 509 knee OA patients were treated with placebo or SFPP at 10, 20, or 40 mg applied on the affected site once daily for 2 weeks. The primary endpoint for efficacy was improvement in knee pain on rising from the chair assessed by visual analog scale (VAS). The other endpoints were clinical symptoms, pain on walking, and global assessment by both investigator and patient. Safety was evaluated by observing adverse events (AEs). Results: VAS change in knee pain from baseline to trial end was dose-dependent, least squares mean was 29.5, 31.5, 32.0, and 35.6 mm in placebo and SFPP 10, 20, and 40 mg, respectively. A significant difference was observed between placebo and SFPP 40 mg (P=0.001). In contrast, the effect of SFPP at a dose ≤20 mg was not significantly different from that of placebo. The proportion of the patients who achieved 50% pain relief was 72.4% in 40 mg and 51.2% in placebo (P

Nearly stoichometric GsAs epilayers doped with Si or Be are grown by molecular beam epitaxy at a low temperature with closely controlled fluxes near the stoichiometric conditions. The dependence of carrier mobility on the trapped carrier concentrations indicates that free carriers are trapped by neutral point defects and change them into ionized ones.

Research describing the influence of electronic states of the surrounding semiconductor matrix on the precipitation of metallic arsenic clusters is presented. In particular clusters in the epilayers of epitaxial gallium arsenide are studied.

GaAs layers grown by molecular beam epitaxy at low temperatures were studied using Raman scattering, x-ray diffraction and transmission electron microscopy.

The influence of annealing on the electronic properties and structure of n- and p-doped low-temperature grown (LTG) GaAs epilayers reveals that point defects control electronic properties. Excess As precipitates produced by annealing reduce the negative influence of point defects on electronic properties. The resistivity of LTG-GaAs epilayers doped with Si- or Be is maximum when annealed at a temperature of 100 degrees Celsius.