This phase 2b, randomized, observer-masked, placebo- and active-controlled, parallel-group, multinational (USA and Japan), multicenter study (NCT03216902) assessed the optimal dose of sepetaprost ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension. After washout, patients ≥18 years (USA) or ≥20 years of age (Japan) received once-daily sepetaprost for 3 months [0.0005% ( = 43); 0.
View Article and Find Full Text PDFIntroduction: This post-marketing observational interim analysis evaluated the 12-month effectiveness and safety of omidenepag isopropyl (OMDI) ophthalmic solution in daily clinical settings.
Methods: This was a multicenter, large-scale, non-interventional, prospective, observational study conducted in Japan. The target enrollment was 3900 patients, and the overall observation period was 12 months.
Purpose: To assess the efficacy and safety of filtration surgery using the EX-PRESS glaucoma filtration device in patients with normal-tension glaucoma (NTG).
Study Design: Prospective, single-arm, multicenter interventional case series.
Methods: Eyes with NTG underwent EX-PRESS implantation with or without cataract surgery.
Purpose: To study the frequencies and factors associated with 4 disc patterns in primary open-angle glaucoma (POAG) identified in population-based studies: focal glaucomatous (FG type), generalized enlargement of cup (GE type), myopic glaucomatous (MG type), and senile sclerotic glaucomatous (SS type) patterns.
Subjects: In total, 270 disc photographs of acceptable quality were extracted from the records of 270 definitive POAG cases diagnosed according to the International Society of Geographical and Epidemiological Ophthalmology Criteria in 2 Japanese population-based glaucoma surveys. One randomly chosen eye from the bilateral POAG cases was included.
In the original publication, the range to derive the P values is incorrectly represented in Table 2 and Table 3. The corrected tables are provided below.
View Article and Find Full Text PDFIntroduction: This was the first exploratory randomized controlled study to compare the efficacy and safety of a preserved tafluprost/timolol fixed combination (TAF/TIM) with a preserved latanoprost/timolol fixed combination (LAT/TIM).
Methods: This prospective, randomized, open-label study was conducted in Japanese patients with primary open-angle glaucoma, including normal-tension glaucoma or ocular hypertension. Following a 4-week LAT/TIM run-in period, eligible patients entered a 12-week treatment period, during which they received either LAT/TIM or TAF/TIM.
Purpose: This study evaluates the effect of tafluprost on visual field progression in normal-tension glaucoma (NTG) in a Japanese population under daily clinical practice settings.
Patients And Methods: This is a post-marketing, multicenter, non-interventional, observational study. Patients with NTG who initiated tafluprost treatment were registered and prospectively observed for 2-3 years to investigate its effectiveness on visual field progression and intraocular pressure (IOP) and safety in Japan.
Purpose: To report the efficacy of the predetermined treatment protocol of the Collaborative Bleb-related Infection Incidence and Treatment Study (CBIITS) for bleb-related infection (BRI) patients.
Methods: A prospective, observational cohort study was conducted at 34 clinical centres in Japan. Nineteen eyes from 19 patients that developed BRI were treated using the CBIITS protocol at 34 clinical centres.
Purpose: To evaluate anxiety felt by glaucoma patients.
Patients And Methods: In total, 472 glaucoma patients responded to a questionnaire on anxiety, subjective symptoms, and vision-related quality of life (VR-QOL) associated with glaucoma. Anxiety was evaluated using the State-Trait Anxiety Inventory (STAI), state anxiety (STAI-State) subscale along with our novel questionnaire, assessing visual function and subjective symptoms, specialized for glaucoma.
Introduction: The aim of this study was to investigate the long-term intraocular pressure (IOP)-lowering effect and safety of tafluprost, a prostaglandin analogue, in actual clinical practice and to determine persistency of tafluprost as an indicator of its benefit-risk balance.
Methods: This was a large-scale, post-marketing, multicenter, non-interventional, open-label, long-term study. Patients with glaucoma or ocular hypertension who initiated tafluprost treatment were registered and prospectively observed over a 2-year period in the real-world setting in Japan.
Purpose: To report the 5-year incidence of visual impairment after mitomycin C-augmented trabeculectomy (MMC trabeculectomy) and the risk factors for visual impairment.
Methods: This is a multicentre prospective observational cohort study. Among glaucoma patients registered in the Collaborative Bleb-related Infection Incidence and Treatment Study performed in Japan, the patients with eyes meeting the following qualifications were included: eyes with primary open-angle glaucoma; eyes with primary angle-closure glaucoma; eyes with exfoliative glaucoma; eyes with ≥3/60 in blindness analysis; and eyes with ≥20/60 in low-vision analysis and visual acuity loss analysis.
Purpose: To investigate the intra-ocular pressure (IOP)-lowering effects and safety of 0.4% ripasudil (K-115), a Rho kinase inhibitor, twice daily for 52 weeks, in patients with open-angle glaucoma or ocular hypertension (OHT).
Methods: In this multicentre, prospective, open-label study, 388 patients with primary open-angle glaucoma, OHT or exfoliation glaucoma were enrolled and 354 of them were subdivided into four cohorts (monotherapy, 173; additive therapy to prostaglandin analogs, 62; β-blockers, 60; or fixed combination drugs, 59).
Purpose: To verify, by use of data collected by the Japan Glaucoma Society Survey of Bleb-related Infection (JGSSBI), that bleb morphology changes within 12 months of the development of bleb-related infection.
Methods: JGSSBI data from 57 eyes of 57 patients with primary open-angle glaucoma and normal tension glaucoma who developed a bleb-related infection were analyzed. Morphological features of the blebs were graded by use of a predetermined grading system.
Importance: Ripasudil hydrochloride hydrate (K-115), a novel rho kinase inhibitor, provides statistically significant intraocular pressure (IOP)-lowering effects and has a tolerable safety profile. However, no studies have evaluated ripasudil combined with β-blockers and prostaglandin analogues.
Objective: To evaluate the additive IOP-lowering effects and the safety of ripasudil, 0.
Purpose: We assessed vision-related quality of life (VR-QOL) in glaucoma patients and examined the relationship between VR-QOL and indices of visual function and subjective symptoms.
Patients And Methods: Four hundred seventy-two glaucoma patients completed a questionnaire concerning VR-QOL and subjective symptoms of glaucoma. VR-QOL was based on 5 subscales selected from the National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25), whereas subjective symptoms were examined using original questions that we prepared.
Purpose: To investigate the intra-ocular pressure (IOP)-lowering effects of a selective Rho kinase inhibitor, ripasudil (K-115), over 24 hr in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).
Methods: In this multicenter, prospective, randomized, open-label, 3-period, Latin-square crossover clinical study, 28 patients with POAG or OHT whose IOP level was 21 mmHg or higher were subdivided into three groups. Each patient was treated with placebo and ripasudil in concentrations of 0.
Purpose: To estimate the risk of blindness following bleb-related infection after trabeculectomy with mitomycin C in open angle glaucoma, utilizing data obtained from two prospective multicenter studies.
Methods: The incidence of bleb-related infection in open angle glaucoma after the first or second glaucoma surgery was calculated using a Kaplan-Meier analysis and data from the Collaborative Bleb-related Infection Incidence and Treatment Study (CBIITS). The rate of blindness following bleb-related infection was calculated using data from the Japan Glaucoma Society Survey of Bleb-related Infection (JGSSBI).
Introduction: This study investigated the intraocular pressure (IOP)-lowering effects and safety of tafluprost ophthalmic solution 0.0015% in actual clinical practice.
Methods: We started a mandatory prospective 2-year observational study, which collected IOP, conjunctival hyperemia score, corneal staining score, and adverse event data from glaucoma and ocular hypertension (OH) patients not previously treated with tafluprost at 2, 12, and 24 months.
Purpose: To report the 5-year incidence of bleb-related infection after mitomycin C-augmented glaucoma filtering surgery and to investigate the risk factors for infections.
Design: Prospective, observational cohort study.
Participants: A total of 1098 eyes of 1098 glaucoma patients who had undergone mitomycin C-augmented trabeculectomy or trabeculectomy combined with phacoemulsification and intraocular lens implantation performed at 34 clinical centers.
Purpose: The aim of this study was to determine the safety, efficacy, and bleb morphology of fornix-based trabeculectomy with mitomycin C using the horizontal suture technique.
Materials And Methods: A retrospective noncomparative case series of 79 eyes of 69 patients, who underwent fornix-based trabeculectomy with mitomycin C, was studied. Conjunctival closure of all eyes was with the horizontal suture technique using 10-0 nylon suture to prevent bleb leakage and improve bleb morphology posttrabeculectomy.
Purpose: To identify the optimal dose of a novel Rho kinase inhibitor, K-115, by assessing dose dependency of the intraocular pressure (IOP)-lowering effects and the safety in patients with primary open-angle glaucoma or ocular hypertension.
Designs: Multicenter, prospective, randomized, placebo-controlled, double-masked, parallel group comparison clinical study.
Methods: After appropriate washout periods, 210 patients with primary open-angle glaucoma or ocular hypertension were subdivided into 4 groups and were treated with K-115 in concentrations of 0.
Purpose: To identify changes in visual acuity and intra-ocular pressure (IOP) 12 months after the development of bleb-related infection.
Methods: Data obtained from 146 eyes of 146 patients with bleb-related infection were analyzed as a part of the Japan Glaucoma Society Survey of Bleb-related Infection. Multiple logistic regression analysis was conducted to identify factors associated with poor prognosis in visual acuity and increased IOP and for being stage III.
Importance: We conducted a series of phase 1 clinical trials to elucidate the efficacy and safety of the selective Rho kinase inhibitor K-115 as a candidate drug for the treatment of glaucoma. We report the intraocular pressure (IOP)-lowering effects and safety of K-115 based on our results.
Objective: To study the IOP-lowering effects and safety of topical administration of a selective Rho kinase inhibitor, K-115, in healthy male adult volunteers.
Nippon Ganka Gakkai Zasshi
October 2012
Objective: To compare the intraocular pressure (IOP)-lowering effect and safety of topical brimonidine to that of timolol, and to study the additive effect of topical brimonidine to topical prostaglandin (PG) analogues in 475 patients with either ocular hypertension or primary open angle glaucoma.
Methods: The primary endpoint was the mean IOP change from the baseline at 0 and 2 hours at week 4.
Results: The mean changes were -4.