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Purpose: To investigate the efficacy and safety of glaucoma medication in Japanese patients, network meta-analysis (NMA) of an intraocular pressure(IOP) reduction, adverse reaction rates and conjunctival congestion rates of major glaucoma drugs used in clinical practice in Japan were conducted using the new drug application (NDA) data. Study design: Scoping network meta-analysis. Methods: Out of all clinical trials in the interview forms of major glaucoma drugs approved in Japan as of July 2015, active-control clinical trials with Japanese patients were identified through screening with specific criteria. The details of IOP reduction, adverse reaction rates and conjunctival hyperemia rates of the trials were collected from published articles, package inserts, interview forms and Summary basis of approval made by Japan Pharmaceutical and Medical Devices Agency (PMDA). The mean difference in IOP reduction, adverse reaction rates, and conjunctival hyperemia rates of eligible trials were assessed using NMA as referenced to those of timolol maleate 0.5%. Results: Eleven multicenter trials of ten medications in total, (five prostaglandin (PG) analogs, three β-blockers, one α-1 blocker, and one α-2 stimulator) were selected. The mean difference in IOP reduction in mmHg with 95% confidence intervals were as follows: bimatoprost −3.00 (−3.71; −2.29), tafluprost −2.45 (−3.65; −1.25), travoprost −2.35 (−3.41; −1.29), and latanoprost −2.05 (−2.72; −1.38). The highest IOP reduction was achieved by PG analogs. Adverse reaction rates and conjunctival hyperemia rates were significantly larger with PG analogs than with other medications. Conclusion: The efficacy and safety of glaucoma medications were assessed by NMA as reference to those of timolol maleate 0.5% in Japanese patients. PG analogs were the most efficacious in reducing IOP. However, PG analogs were also associated with higher rates of adverse reactions and conjunctival hyperemia. [ABSTRACT FROM AUTHOR]

Introduction: 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. The efficacy endpoint was the change in intraocular pressure (IOP) from baseline to week 12 and the safety endpoints included the changes from baseline to week 12 in superficial punctate keratopathy (SPK) score, tear breakup time (TBUT), and hyperemia score, as well as adverse events (AEs). At week 6, ocular symptoms were evaluated using a questionnaire.Results: In total, 131 patients provided informed consent. Of these, 115 completed the run-in period and were assigned to receive TAF/TIM (n = 60) or LAT/TIM (n = 55). At week 12, there were no significant differences between the TAF/TIM and LAT/TIM groups in the change from baseline in trough IOP and IOP at 4-6 h after instillation. There were no significant differences between the two groups in the change from baseline to week 12 in SPK score, TBUT, and hyperemia score. However, only in the TAF/TIM group, the total SPK score and the inferior cornea SPK score were significantly lower at week 12 compared with baseline. Eye irritation and eye pain were significantly decreased in the TAF/TIM group compared with the LAT/TIM group. Two treatment-related AEs were reported in the TAF/TIM group (3.3%) and none in the LAT/TIM group, while no serious AEs were reported in either group.Conclusion: TAF/TIM is as effective as LAT/TIM in terms of IOP-reducing effect, with fewer ocular symptoms. TAF/TIM was associated with a significant improvement in SPK scores.Trial Registration: UMIN Clinical Trials Registry Identifier, UMIN000023862.Funding: Santen Pharmaceutical Co., Ltd., Osaka, Japan. [ABSTRACT FROM AUTHOR]

Introduction: The efficacy of lowering intraocular pressure (IOP) and safety of switching to travoprost/timolol fixed combination ophthalmic solution (Duotrav(®), Alcon Laboratories, Inc., Fort Worth, TX, USA) in patients with primary open-angle glaucoma, normal tension glaucoma or ocular hypertension undergoing prostaglandin analog (PGA) monotherapy was investigated.Methods: Patients treated with travoprost, latanoprost, tafluprost, or bimatoprost for ≥3 months and requiring additional medication were switched to Duotrav without washout. Baseline IOP was calculated from measurements at two visits during PGA monotherapy. IOP reductions at 4, 8, and 12 weeks after switching to Duotrav and adverse events were assessed.Results: Of 162 patients enrolled, 157 patients (96.9%) with ≥4 weeks of follow-up after switching to Duotrav were analyzed. The mean IOP decreased significantly (baseline = 16.3 ± 3.1 mmHg; 4 weeks = 14.6 ± 3.1 mmHg, 8 weeks = 14.7 ± 3.3 mmHg, 12 weeks = 14.6 ± 3.2 mmHg; all P < 0.0001). When study eyes were divided into three groups according to baseline IOP (≥19 mmHg: 33 eyes, 21.0%; ≥15 to <19 mmHg: 78 eyes, 49.7%; <15 mmHg: 46 eyes, 29.3%), all groups showed significant IOP reductions (P = 0.0324 ~ P < 0.0001) after switching to Duotrav. Twenty-seven of 166 patients (16.3%) in the safety analysis experienced adverse events and 26/166 patients (15.7%) experienced adverse events, for which a relationship to Duotrav could not be ruled out. Adverse events in five patients led to treatment discontinuation (eye pruritus; eye irritation; increased blood pressure and rash; increased blurred vision; deepening of the eyelid sulcus and blepharoptosis). Twelve weeks after treatment switching, eyelash changes, blepharal pigmentation and deepening of the eyelid sulcus occurred in 42 (26.8%), 29 (18.5%), and 13 (8.3%) cases, respectively, among 157 patients with follow-up. There was no significant worsening from baseline for superficial punctate keratopathy (SPK) or conjunctival hyperemia after switching (SPK score: baseline = 0.58 ± 1.31; 12 weeks = 0.92 ± 1.76, P = 0.1819; conjunctival hyperemia score: baseline = 0.41 ± 0.64; 12 weeks = 0.49 ± 0.63, P = 0.3774).Conclusion: Our findings confirm that switching to Duotrav(®) in PGA monotherapy patients shows IOP-lowering effect with minimal safety concerns.Funding: Japan Association of Health Service and Alcon Japan. Ltd.Trial Registration: UMIN Clinical Trials Registry identifier, UMIN000007028. [ABSTRACT FROM AUTHOR]

Purpose. We retrospectively reviewed medical records of glaucoma patients to investigate how switching medications may affect intraocular pressure (IOP) management. Three concomitant medications were changed to two medications: one combination drop and one single-action drop. Associated adverse effects were also examined. Subjects and Methods. A total of 112 patients with primary open-angle glaucoma or ocular hypertension were examined. All patients were concomitantly using a prostaglandin (PG) analog, a μ-blocker, and a carbonic anhydrate inhibitor (CAI). Fifty-five patients began using latanoprost (PG analog)/timolol (μ-blocker) fixed-combination (LTFC) drops and a CAI (group 1), and 57 patients began using dorzolamide (CAI)/timolol fixed-combination (DTFC) drops and a PG analog (group 2). The IOP was measured every 6 months for 2 years following medication changes. Changes in visual field mean deviation (MD) and medication discontinuations were also examined. Results. There were no significant differences in IOP or MD values before and after medication changes in either group. The proportion of medication discontinuations, uncontrolled IOP, and adverse reactions was similar in both groups. Conclusion. Switching patients from multiple single-action medications to combination medications was not associated with changes in IOP, visual field testing results, or adverse event frequency. [ABSTRACT FROM AUTHOR]

Purpose. To evaluate the effect on intraocular pressure (IOP) of switching from latanoprost and travoprost monotherapy to timolol fixed combinations in Japanese patients with normal-tension glaucoma (NTG). Methods. 27 NTG patients (54 eyes) were compared IOP, superficial punctuate keratitis (SPK) scores, and conjunctival injection scores in eyes treated with prostaglandin (PG) or PG analog/beta-blocker (PG/b) fixed-combination 6 months after the change in therapy. Results. The mean baseline intraocular pressure was 17.4 ± 1.59 mmHg in eyes receiving PG therapy only and 17.4 ± 1.69 mmHg in eyes switched to PG/b. Switching to fixed combination therapy from PG monotherapy, the mean IOP was 13.1 ± 1.79 mmHg (P < 0.001) (-24.71% reduction from baseline) at 6 months. The mean conjunctival injection score was 0.69 for eyes on PG monotherapy and 0.56 for eyes on fixed combination therapy (P = 0.028). The mean SPK scores were 0.46 and 0.53. This difference was not statistically significant (P = 0.463). Conclusions. Switching from PG monotherapy to PG/b fixed combination therapy for NTG resulted in a greater intraocular pressure reduction than PG alone without increasing the number of instillations. [ABSTRACT FROM AUTHOR]

Purpose: Latanoprost 0.005%/timolol maleate 0.5% combination eye drops are now available in Japan. The aim of the present study was to investigate the prospective intraocular pressure (IOP) reduction effects and adherence with the combination eye drops in Japanese patients. Methods: The subjects were 162 patients (162 eyes) with glaucoma or ocular hypertension concomitantly using latanoprost 0.005% and timolol maleate 0.5% eye drops. Concomitant use of the 2 eye drops was stopped, and patients were switched to the latanoprost 0.005%/timolol maleate 0.5% combination eye drops without any washout period. IOP was measured before the switch, and at 1 and 3 months after the switch, and then compared. A questionnaire survey on adherence was also conducted 1 month after the switch. Results: IOP was the same before and after the switch: 15.2±3.3 mmHg before the switch, 14.9±3.0 mmHg 1 month after the switch, and 15.1±3.2 mmHg 3 months after the switch. According to the questionnaire survey, the frequency of forgetting to administer eye drops decreased with the switch, but 45.1% of the patients experienced irritation. About 82.1% replied that they preferred the latanoprost 0.005%/timolol maleate 0.5% combination eye drops. By the third month after the switch, 13 patients (8.0%) had discontinued the eye drops due to side effects or insufficient IOP reduction. Conclusion: The switch from the concomitant use of latanoprost 0.005% and timolol maleate 0.5% eye drops to latanoprost 0.005%/timolol maleate 0.5% combination eye drops improved adherence and helped maintain IOP. [ABSTRACT FROM AUTHOR]