NCT01369771已完成4 期
An Open-label, Phase IV, Pilot Study, to Evaluate Confocal Microscopic Findings of Cornea, Ocular Signs and Symptoms in Patients With OH or OAG Switching From Latanoprost 0.005% to Preservative Free Tafluprost 0.0015% Eye Drops
FinnMedi Oy1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from screening in corneal confocal microscopic findings at month 12
研究概览
简要总结
The objective of this study is to investigate corneal confocal microscopic findings, ocular signs and symptoms in patients on treatment with the preserved prostaglandin analogue latanoprost 0.005% eye drops (Xalatan®) and after the switch to preservative-free prostaglandin analog tafluprost 0.0015% eye drops (Taflotan®). Patients who have been using latanoprost as their prior medication (at least 6 months) and who fulfil all the inclusion criteria including the specified ocular symptoms and signs, will switch from latanoprost 0.005% eye drops to the assigned preservative-free tafluprost 0.0015% eye drops for twelve (12) months.
详细描述
Primary outcome measures:
- Change from screening in corneal confocal microscopic findings at month 12
- Change from screening in ocular symptoms upon non-instillation at month 12
- Change from screening in ocular signs at month 12
Safety and QoL variables: 4. Descriptive statistics, identification of change(s) from screening
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have provided a written informed consent
- •Aged 18 years or more
- •A diagnosis of ocular hypertension or open-angle glaucoma (either POAG or capsular 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)
- •In the Screening visit evaluation, the presence of:
- •At least two ocular symptoms considered for the two eyes together (irritation/burning/stinging, foreign body sensation, tearing, itching or dry eye sensation) of at least mild severity (grade ≥ 2) upon non-instillation OR One 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 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
- •A best corrected ETDRS visual acuity score of +0.6 logMAR or better in both eyes
- •Negative pregnancy test result at the screening visit, or, consistently and correctly used reliable method of contraception during the study
- •Are willing to follow instructions
排除标准
- •Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
- •Anterior chamber angle in either eye to be treated less than grade 2 according to Schaffer classification as measured by gonioscopy
- •Any corneal abnormality or other condition preventing reliable applanation tonometry, including prior refractive eye surgery
- •IOP greater than 22 mmHg at 15:00 IOP measurement in either eye at Screening/Baseline visit
- •Use of preserved eye drops (other than latanoprost) including artificial tears at screening or within two weeks prior to screening visit
- •Diagnosis of angle-closure glaucoma or secondary glaucoma other than capsular glaucoma in either eye
- •Suspected contraindication to tafluprost therapy (hypersensitivity to tafluprost or any of the excipients)
- •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
- •Use of contact lenses at Screening or during the study
- •Any ocular (e.g. aphakia, pseudophakia with torn posterior lens capsule2 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
- •Current alcohol or drug abuse
- •Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days
研究组 & 干预措施
Tafluprost 0.0015%
Experimental
Open, one arm study. Patients who have been using latanoprost 0.005% eye drops (Xalatan®) as their prior medication (at least 6 months) and who fulfil all the inclusion criteria including the specified ocular symptoms and signs, will switch from latanoprost to the assigned preservative-free tafluprost 0.0015% (Taflotan®)eye drops for twelve (12) months.
干预措施: Tafluprost 0.0015% (Drug)
结局指标
主要结局
Change from screening in corneal confocal microscopic findings at month 12
时间窗: Baseline and Month 12
次要结局
- Change from screening in ocular symptoms and signs upon non-instillation(Baseline and Month 12)
研究者
研究点 (1)
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