EUCTR2016-004317-27-Outside-EU/EEA进行中（未招募）1 期
A Comparative Study of Olopatadine Hydrochloride Ophthalmic Solution 0.2% QD vs Olopatadine Hydrochloride OphthalmicSolution 0.1% BID in the Treatment of Allergic Conjunctivitis in Chinese Subjects - Olopatadine Hydrochloride Ophthalmic Solution Study in Chinese Subjects
Alcon China Ophthalmic0 个研究点目标入组 250 人开始时间: 2017年7月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
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
- •Chinese ethnicity; History of allergic conjunctivitis within the last 2 years; Positive skin prick test or skin intradermal test documented by a lab report within 24 months of, or at the baseline visit; Clinical diagnosis of allergic conjunctivitis with specific signs and symptoms; Understand and sign an informed consent form; Willing and able to make required study visits and follow study instructions, and comply with dosing study medication as instructed; Other protocol-specified inclusion criteria may apply.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Contraindications or hypersensitivity to study medications or their components;•Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal) in either eye;•Any ocular condition that could affect the study outcomes;•Presumed or actual ocular infection or history of ocular herpes in either eye;•Known history of retinal detachment, diabetic retinopathy, or any progressive retinal disease;•Willing and able to avoid the use of any other topical ocular medication(s) (including artificial tear products);•Any significant illness that could be expected to interfere with the study, particularly any autoimmune disease;•Intraocular surgery in either eye within 6 months, or ocular laser surgery in either eye within 3 months, or anticipation of ocular surgery during the study; ocular trauma in either eye within 3 months of baseline visit;•Clinically relevant recent (within 6 months of baseline visit) history of or current severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, autoimmune disease and other relevant systemic diseases that would preclude the safe administration of a topical antihistamine/mast cell stabilizer in the opinion of the Investigator;•Use of systemic medication(s) on a chronic dosing regimen for less than 1 month or have changed dosage within the month prior to baseline visit;•Use of any disallowed medication (topical, topical ophthalmic, systemic and/or injectable) during the period indicated prior to baseline visit. These medications are also not allowed during the study. Disallowed medications include all anti-allergy therapies including those contained in prescription or over-the-counter sleeping aids;•Use of cold compresses on the eyes during the course of the study;•Cannot be dosed in both eyes;•Cannot avoid contact lens wear during the course of the study;•Therapy with another investigational agent within 30 days of baseline visit, or during the study;•Women of childbearing potential who are pregnant, intend to become pregnant during the study period, breast-feeding, or not using adequate birth control methods;•Other protocol-specified exclusion criteria may apply.
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