Abstract:
OBJECTIVE:The purpose of this study was to evaluate the safety and clinical efficacy of alcaftadine 0.25% ophthalmic solution, a new topical anti-allergic agent for the prevention of the signs and symptoms of allergic conjunctivitis induced by conjunctival allergen challenge (CAC). STUDY DESIGN AND METHODS:This two-arm, double-masked, multi-center, placebo-controlled Phase III study (NCT00889330) enrolled healthy volunteers (N = 58) with a history of allergic conjunctivitis. Subjects ≥10 years of age with a reproducible, positive reaction to a CAC were randomized to receive either one drop of alcaftadine 0.25% ophthalmic solution bilaterally or vehicle bilaterally. After 16 hours (Visit 3) and 15 minutes (Visit 4), a CAC was performed and ocular and nasal symptoms of allergy were graded over a 20-minute period. Clinical and statistical significance were evaluated. MAIN OUTCOME MEASURES:The primary endpoints were ocular itching and conjunctival redness. The secondary endpoints were all other signs and symptoms of allergic conjunctivitis. Visual acuity, slit lamp biomicroscopy and adverse event reporting were the predetermined safety measures. RESULTS:Alcaftadine was effective in the prevention of ocular itching based on both clinically relevant and statistically significant differences compared with vehicle (placebo). Alcaftadine significantly reduced conjunctival redness, and almost all other allergic signs and symptoms at both 15 minutes and 16 hours after drug administration. No significant safety issues were reported. Between-group differences in ocular itching were higher 16 hours after drug administration than at 15 minutes after drug administration. CONCLUSIONS:With an onset of action within 3 minutes and a duration of action of at least 16 hours, the statistically and clinically significant effect of alcaftadine 0.25% on itching make it an important addition to therapy for ocular allergy. Additional studies are warranted to better understand the mechanisms affording a fast onset and prolonged duration of action.
journal_name
Curr Med Res Opinjournal_title
Current medical research and opinionauthors
Torkildsen G,Shedden Adoi
10.1185/03007995.2010.548797subject
Has Abstractpub_date
2011-03-01 00:00:00pages
623-31issue
3eissn
0300-7995issn
1473-4877journal_volume
27pub_type
杂志文章,多中心研究,随机对照试验abstract:OBJECTIVES:We conducted an adjusted comparison of progression-free survival (PFS) and overall survival (OS) for daratumumab monotherapy versus standard of care, as observed in a real-world historical cohort of heavily pretreated multiple myeloma patients from Czech Republic. METHODS:Using longitudinal chart data from ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2017.1410121
更新日期:2018-05-01 00:00:00
abstract:BACKGROUND:The ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines development group examined the properties of oral H(1)-antihistamines and made proposals about an 'optimal' drug. Several criteria should be met by oral H(1)-antihistamines in terms of their pharmacological, and clinical efficacy and safety pro...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2011.648263
更新日期:2012-01-01 00:00:00
abstract::The bioavailability of ofloxacin after a single dose of one of two tablet formulations (200 or 400 mg) or a liquid formulation (1.67 mg/ml) was investigated in 24 healthy male volunteers in an open randomized, crossover design study with a 5-day wash-out period between doses. Plasma concentrations of ofloxacin were de...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007999109112662
更新日期:1991-01-01 00:00:00
abstract::One hundred and eight patients who had been taking phenytoin for a year or more, either alone or in combination with other drugs, were examined for gum hypertrophy by three observers independently. Approximately 90% of the patients showed either mild or no gum hypertrophy and severe swelling occurred in only 1%. The o...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007998809111114
更新日期:1988-01-01 00:00:00
abstract:BACKGROUND:Description of risk of cardiovascular (CV) events associated with diabetes is evolving. This US-based real-world study estimated risk of future CV events and heart failure (HF) from type 2 diabetes (T2DM) only, prior CV events only or T2DM plus prior CV events, versus controls, and evaluated healthcare resou...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2020.1832455
更新日期:2020-12-01 00:00:00
abstract::An investigator-blind, parallel-group, multicentre study was undertaken to compare the efficacy and tolerability of once-daily, sustained-release (s-r) ibuprofen and diclofenac sodium in patients (mean age 59.8 years) suffering from painful osteoarthritis affecting chiefly the knee and/or hip. Patients attending eight...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1185/03007999609115224
更新日期:1996-01-01 00:00:00
abstract:BACKGROUND:Tenofovir disoproxil fumarate (TDF)-based regimens have been associated with impaired kidney function and loss of bone mineral density among patients living with HIV (PLWH). We assess the association between TDF exposure and the odds of chronic kidney disease (CKD) and osteoporotic fracture in HIV patients. ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2020.1816538
更新日期:2020-10-01 00:00:00
abstract::A double-blind, multi-centre trial was carried out in 191 patients with acute musculoskeletal conditions to compare the efficacy of naproxen and indomethacin. Patients were randomly allocated to receive either 250 mg naproxen or 50 mg indomethacin twice daily. Treatment was for 7 or 14 days. The results, assessed by t...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007997609109332
更新日期:1976-01-01 00:00:00
abstract::Optimal management of hypertension has been shown to reduce the risk of stroke. In recent years, newer classes of antihypertensive such as the angiotensin II (Ang II) antagonists have become available. Results from the Losartan Intervention for Endpoint reduction in hypertension (LIFE) study suggest the utility of thi...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/030079904X10160
更新日期:2004-11-01 00:00:00
abstract:OBJECTIVE:To compare the risk of developing uveitis in patients initiating anti-tumor necrosis factor (anti-TNF) agents (adalimumab, etanercept, and infliximab) for ankylosing spondylitis (AS). METHODS:Anti-TNF-naive patients with a diagnosis of AS and without a history of uveitis (N = 2115) who subsequently initiated...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2014.969368
更新日期:2014-12-01 00:00:00
abstract::The therapeutic efficacy of cimetidine given as 400 mg twice daily was compared to that of cimetidine given as 1.0 g daily in 4 divided doses (200 mg 3-times daily and 400 mg at night) in two groups of 25 patients (total 50 patients) with active duodenal ulceration. After 4 weeks, healing rates of 72% and 76%, respect...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998509109626
更新日期:1985-01-01 00:00:00
abstract:OBJECTIVE:Clinical evidence supports the use of cardiac resynchronization therapy (CRT) in advanced heart failure, but its cost-effectiveness is still unclear. This analysis assessed the economic and health consequences in the UK of implanting a CRT in patients with NYHA class III-IV heart failure. METHODS:A discrete ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079906X112516
更新日期:2006-06-01 00:00:00
abstract::A randomized four-way crossover study was carried out in 12 healthy volunteers to investigate the pharmacokinetics of a new oral combination of frusemide (40 mg) and amiloride (5 mg), formulated as a single tablet. The experimental design of this bioequivalence study used commercially-available 40 mg frusemide tablets...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998409109572
更新日期:1984-01-01 00:00:00
abstract:OBJECTIVE:Research indicates that insomnia may contribute significantly to healthcare costs; however, information on the effects of treatments on costs has not been thoroughly published. This study presents predictive models that forecast, from the perspective of commercial managed care, the effects of insomnia medicat...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079907X199619
更新日期:2007-06-01 00:00:00
abstract::Objective: The aim of this study was to investigate the impact of methodological choices in a meta-analysis of real-world evidence (RWE) comparing three non-vitamin-K antagonist oral anticoagulants with vitamin K antagonists (VKAs) for the treatment of patients with non-valvular atrial fibrillation (NVAF). Methods: Th...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析
doi:10.1080/03007995.2019.1647020
更新日期:2019-11-01 00:00:00
abstract::This commentary critically evaluates the limitations of genetic risk predictions in multifactorial disease, with specific reference to age-related macular degeneration (AMD). AMD is a common blinding disease with 33 million people worldwide experiencing vision impairment. Although gene polymorphism combinations infer ...
journal_title:Current medical research and opinion
pub_type: 社论
doi:10.1185/03007995.2011.603301
更新日期:2011-09-01 00:00:00
abstract::Objectives Real-world patient outcomes data is scarce concerning the high disease burden of IBS-C. The aim of this study was to compare patient-reported symptom control, health-related quality of life (HRQoL), resource utilization, and treatment satisfaction of lubiprostone vs non-lubiprostone treatment for irritable ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2016.1150262
更新日期:2016-05-01 00:00:00
abstract::Daily fluctuations in plasma cortisol levels were studied in three groups of children with rheumatoid arthritis. One group was untreated with hormones, the second treated with a depot preparation of tetracosactrin, and the third group with corticosteroid hormones. The results obtained were compared with the rhythm in ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007997709109336
更新日期:1977-01-01 00:00:00
abstract::Two new benzodiazepines, potassium clorazepate (15 mg. at night), and lorazepam (1 mg. t.d.s.) were compared in 50 patients presenting with anxiety in general practice. The response to treatment was assessed clinically and for patient acceptance. The single-dose regime of potassium clorazepate was significantly better...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007997409111880
更新日期:1974-01-01 00:00:00
abstract:OBJECTIVE:To estimate the costs and consequences of using pamidronate compared to zoledronic acid in the prophylactic management of skeletal morbidity among breast cancer patients in the UK. DESIGN AND SETTING:This was a modelling study performed from the perspective of the UK's National Health Service (NHS). METHODS...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079905X40472
更新日期:2005-05-01 00:00:00
abstract:OBJECTIVE:To evaluate knowledge about risks, prevention and consequences of infection with hepatitis B virus (HBV) among travellers from four low HBV risk, European countries. METHODS:Individuals from an internet panel and based in the Czech Republic, the Netherlands, Spain and Sweden were invited to take part in an o...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2010.546392
更新日期:2011-03-01 00:00:00
abstract:OBJECTIVE:Self-reported healthcare resource utilization (HRU), medication out-of-pocket (OOP) expenditures and impact of OOP expenses on HRU were assessed for respondents with type 2 diabetes mellitus (T2DM) or elevated cardiometabolic risk. METHODS:The 5-year longitudinal SHIELD study surveyed a stratified sample of ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007990802520045
更新日期:2008-12-01 00:00:00
abstract:OBJECTIVE:Vildagliptin is a potent and selective dipeptidyl peptidase-IV (DPP-4) inhibitor that improves glycemic control in patients with type 2 diabetes by increasing alpha and beta-cell responsiveness to glucose. This study assessed the effect of multiple doses of vildagliptin 100 mg once daily on warfarin pharmacok...
journal_title:Current medical research and opinion
pub_type: 杂志文章,随机对照试验
doi:10.1185/030079907x188008
更新日期:2007-05-01 00:00:00
abstract:INTRODUCTION:Azelastine hydrochloride (Astelin) nasal spray 0.1% solution is a second-generation intranasal antihistamine available in the US for treatment of both seasonal allergic rhinitis (SAR) and nonallergic vasomotor rhinitis (VMR). SCOPE:Searches of journal articles including the title word 'azelastine' from 19...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/030079907X226302
更新日期:2007-10-01 00:00:00
abstract:OBJECTIVE:To investigate whether gum chewing affects perceived levels of everyday stress among persons who (1) regularly chew gum or (2) do not chew gum on a regular basis. RESEARCH DESIGN AND METHODS:Two Internet-based studies were conducted. Study 1 enrolled participants who chewed gum > or =4 days per week, chewed ...
journal_title:Current medical research and opinion
pub_type: 杂志文章,随机对照试验
doi:10.1185/03007990902959283
更新日期:2009-06-01 00:00:00
abstract::Objective: The aim of this study was to provide recommendations for improving the design of subsequent studies through analysis of the registered coronavirus disease 2019 (COVID-19) clinical trials.Methods: A retrospective analysis of 189 trial retrievals achieved on 20 February 2020.Results: A total of 189 trials are...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2020.1771294
更新日期:2020-07-01 00:00:00
abstract::Alzheimer's disease (AD) is a progressive neurodegenerative disorder of the elderly, characterised by widespread loss of central cholinergic function. The only symptomatic treatment proven effective to date is the use of cholinesterase (ChE) inhibitors to augment surviving cholinergic activity. ChE inhibitors act on t...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/0300799039117057
更新日期:2001-01-01 00:00:00
abstract::Migraine is a very common disorder, affecting about 11% of adult populations in Western countries. Prevalence is highest during the peak productive years--between the ages of 25 and 55. The prevalence is higher in females than males at all post-pubertal ages, but the sex ratio varies with age. In the United States, mi...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/0300799039117005
更新日期:2001-01-01 00:00:00
abstract:OBJECTIVE:Postpartum depression (PPD) is the most common medical complication of childbirth. PPD can be disabling, with potential negative effects on maternal health-related quality-of-life (HRQoL) as well as on children and partners. The objective of this study was to systematically review and summarize recently publi...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2018.1552039
更新日期:2019-03-01 00:00:00
abstract::Forty patients with definite or classical rheumatoid arthritis were entered for 3 months in a double-blind trial, 20 patients each on 200 mg flurbiprofen or 4.0 g enteric-coated aspirin daily. Statistically significant improvements (Page Test, p less than 0.05) on flurbiprofen were reported during the course of the st...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998109114278
更新日期:1981-01-01 00:00:00