EUCTR2007-004872-37-SE进行中（未招募）不适用
A phase IIIb study on the changes in ocular signs, symptoms and conjunctival inflammatory markers in patients with ocular hypertension or open-angle glaucoma switched from preserved latanoprost 0.005% eye drops to preservative free tafluprost 0.0015% eye drops.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Santen Oy
- 入组人数
- 150
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
- •Patients of any race and either sex meeting all of the following criteria will be considered eligible for this study:
- •1.Aged 18 years or more
- •2.A diagnosis of ocular hypertension or open-angle glaucoma in one or both eyes, for which the patient has been regularly using latanoprost 0.005% (Xalatan®) for at least six months before Screening (confirmed in anamnesis).
- •3.In the Screening visit evaluation, the presence of:
- •oAt least two ocular symptoms (irritation/burning/stinging, foreign body sensation, tearing, itching or dry eye sensation) of at least mild severity (grade = 2) upon non-instillation and considered for the two eyes together
- •oOne ocular symptom of at least mild severity (grade = 2) upon non-instillation AND at least one of the following ocular signs in either eye with prior treatment:
- •Fluorescein tear break-up time (fBUT): less than 10 seconds
- •Corneal and conjunctival fluorescein staining:
- •?Corneal fluorescein staining score of at least grade I AND/OR
- •?Combined nasal and temporal staining scores of at least grade II
- •Blepharitis of at least mild severity (grade = 1)
- •Conjunctival redness/hyperemia of at least mild severity (grade 1)
- •Tear production 10 mm or less on Schirmer test
- •4.A best corrected ETDRS visual acuity score of +0.6 logMAR or better in both eyes
- •5.Are willing to follow instructions
- •6.Have provided a written informed consent
- •Are the trial subjects under 18? no
- •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.Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception1
- •2.Anterior chamber angle in either eye to be treated less than grade 2 according to Schaffer classification as measured by gonioscopy
- •3.Any corneal abnormality or other condition preventing reliable applanation tonometry, including prior refractive eye surgery
- •4.IOP greater than 22 mmHg at 15:00 IOP measurement in either eye at Screening/Baseline visit
- •5.Use of preserved artificial tears at screening or within two weeks prior to screening visit
- •6.Diagnosis of angle-closure glaucoma or secondary glaucoma other than capsular glaucoma in either eye
- •7.Suspected contraindication to tafluprost therapy (hypersensitivity to tafluprost or any of the excipients).
- •8.Glaucoma filtration surgery or any other ocular surgery (including ocular laser procedures) within 6 months prior to Screening in eye(s) to be treated with study medication
- •9.Use of contact lenses at Screening or during the study
- •10.Any ocular (e.g. aphakia, pseudophakia with torn posterior lens capsule or anterior chamber lenses, known risk factors for cystoid macular oedema or iritis/uveitis), systemic or psychiatric disease/condition (e.g. uncontrolled arterial hypertension, diabetes) that may put the patient at a significant risk or may confound the study results or may interfere significantly with the patient’s participation in the study as judged by the investigator
- •11.Current alcohol or drug abuse
- •12.Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days
- •1 A reliable method of contraception is defined as sterilization or those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
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