EUCTR2006-005681-39-IT进行中（未招募）不适用
A RANDOMIZED, DOUBLE-BLIND, MULTICENTER PARALLEL GROUP STUDY ON EFFICACY AND SAFETY OF KETOTIFEN FUMARATE 0.05 OPHTHALMIC SOLUTION VERSUS KETOTIFEN FUMARATE 0.025 - KETOTIFENE 0.05
FARMIGEA0 个研究点目标入组 180 人开始时间: 2007年2月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Written informed consent. 2.Outpatients, male or female, aged 12 years or older. 3.History of ocular allergies for at least 2 years, documented, within the past 12 months, by positive skin testing prick or intradermal methods or by adequately validated in vitro tests for specific IgE e.g., RAST, PRIST to the relevant allergens for the geographic area of the study or for the local environment. 4.Ocular symptoms of allergy stared at least 24 hours preceding enrolment and having a self-rated sum score equal of more than 6 for itching, tearing and redness. 5.Ability to self-instil ophthalmic solutions
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception. 2.History of glaucoma. 3.Known history of retinal detachment, diabetic retinopathy, or progressive retinal disease. 4.Patients with suspected or known hypersensitivity to the study products or their excipients. 5.Patients already enrolled in this study or patients who have received any other investigational drug within 1 month prior to study entry, or have such treatment planned for the study period. 6.Presence of active ocular infection. 7.Pre-treatment 24 hours with antibiotic for any ophthalmic disease. 8.Documented evidence of acute or significant chronic sinusitis. 9.Clinically significant blepharitis, follicular conjunctivitis, iritis or pterygium. 10.History or diagnosis of dry eye. 11.History or diagnosis of vernal kerato-conjunctivitis VKC or atopic kerato-conjunctivitis AKC . 12.Ocular surgical intervention within 3 months or during the study. 13.History of refractive surgery within 6 months or during the study. 14.Use of contact lenses within 2 days before randomization. 15.Topical ophthalmic and/or nasal medications suspended after the following washout periods or their systemic formulation not in a stable therapeutic regime after the following washout periods.Corticosteroids 1 month; Mastcell stabilizers 2 weeks Loratadine Clarytin 2 weeks; Decongestants 3 days; Antihistamines 3 days 16.Anti-allergy immunotherapy desensitising subjects with increase of allergen challenges in the previous two years or still ongoing. 17.Immunotherapy, including systemic corticosteroids, started or changed in dose, less than one month preceding enrolment. 18.Chronic use of concomitant medications e.g., tricyclic antidepressants that would affect assessment of the effectiveness of the study medication. 19.Patients requiring treatment during the study period with drugs not permitted by the clinical study protocol. 20.Patients presenting poor reliability e.g. history of alcohol or drug abuse, bad mental conditions, planned travel outside the study area for a substantial portion of the study period .
研究者
相似试验
已完成
不适用
A MULTICENTER DOUBLE BLIND, RANDOMIZED, PARALLEL GROUP STUDY TO EVALUATE THE EFFECTS OF TWO DIFFERENT DOSIS OF LOSARTAN ON MORBIDITY AND MORTALITY IN PATIENTS WITH SYMPTOMATIC HEART FAILURE INTOLERANT TO ACE INHIBITOR TREATMENT-I50I50PER-060-01MERCK SHARP & DOHME PERU S.R.L.,
已完成
不适用
A-J44 Other chronic obstructive pulmonary diseaseOther chronic obstructive pulmonary diseaseJ44PER-056-15Pearl Therapeutics Inc.,191
已完成
不适用
A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED, PHASE III EFFICACY AND SAFETY STUDY OF BENRALIZUMAB (MEDI-563) ADDED TO HIGH-DOSE INHALED CORTICOSTEROID PLUS LONG-ACTING β2 AGONIST IN PATIENTS WITH UNCONTROLLED ASTHMA (SIROCCO)-J45J45PER-058-13ASTRAZENECA PERU S.A.,96
未知
不适用
A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED, PHASE 3 EFFICACY AND SAFETY STUDY OF BENRALIZUMAB (MEDI-563) ADDED TO MEDIUM-DOSE INHALED CORTICOSTEROID PLUS LONG-ACTING β2 AGONIST IN PATIENTS WITH UNCONTROLLED ASTHMA (PAMPERO)-J45J45PER-077-13ASTRAZENECA - PERU,
已完成
不适用
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, STUDY OF 12 WEEKS OF DURATION TO EVALUATE THE EFFICACY AND SAFETY OF MK-0524B (IN CODMINISTRATION OF DOSES OF MK-0524A AND SIMVASTATIN TABLETS) AGAINST ATORVASTATIN IN PATIENTS WITH HYPERLIPIDEMIA MIXEDPER-070-08MERCK SHARP & DOHME PERU S.R.L.,9