An Open, Non-randomized Study on the Effect of Changing From Preserved Prostaglandin Formulations to Preservative Free Tafluprost (Saflutan® Augentropfen) in Patients With Ocular Hypertension or Primary Open Angle Glaucoma on Tear Film Thickness
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
- Tear film thickness
研究概览
简要总结
Studies have shown that ocular surface disease (OSD) is common among patients with glaucoma with a prevalence of 50% or more. The percentage of affected patients appears to increase with increasing number of topical anti-glaucoma products instilled. Both pre-clinical and clinical work has indicated that the preservatives used in anti-glaucoma drops, particularly benzalkonium chloride, are mainly responsible for this detrimental effect. As such more and more anti-glaucoma drugs without preservatives entered the market.
To prove that switching from preserved to unpreserved antiglaucoma medication improves the signs and symptom of OSD is, however, not easy. This is on the one hand related to the physiological variability of these parameters over time and on the other hand to the poor association between signs and symptoms. Recently, a new method for measuring tear film thickness (TFT) using ultra-high resolution optical coherence tomography (OCT) has been introduced. Using this method, it has been shown that there is a correlation between reduced TFT and OSD symptoms. In the present study, it is hypothesized that changing patients who are on preserved prostaglandin formulations to preservative free tafluprost may be associated with an increase in TFT.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged over 18 years
- •Diagnosed primary open angle glaucoma treated with preserved prostaglandins for at least 6 months OR
- •Patients with ocular hypertension treated with preserved prostaglandins for at least 6 months
- •IOP ≤ 21 mmHg in the study eye at the screening examination (under treatment)
- •Mean TFT at the screening visit ≤ 6µm in the study eye
- •At least 2 symptoms of dry eye syndrome in the study eye (itching, stinging, blurred vision, foreign body sensation, debris, conjunctival redness) since at least one month
- •Tear break up time ≤ 10sec
排除标准
- •Participation in a clinical trial in the 3 weeks before the screening visit
- •Severe visual field loss as defined as an MD of -15 or worse in the study eye
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
- •Sjögren's syndrome
- •Stevens-Johnson syndrome
- •Presence or history of a severe ocular condition that will interfere with the study aim as judged by the clinical investigator
- •Presence or history of allergic conjunctivitis
- •Treatment with corticosteroids in the 4 weeks preceding the study
- •Wearing of contact lenses
- •Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except glaucoma medication or topical lubricants
- •Ocular infection
- •Ocular surgery in the 6 months preceding the study (except laser trabeculoplasty)
- •Pregnancy, planned pregnancy or lactating
- •Contraindication against the use of topical prostaglandin therapy
研究组 & 干预措施
Patients with glaucoma or ocular hypertension
干预措施: Tafluprost 15µg/ml (Drug)
结局指标
主要结局
Tear film thickness
时间窗: Change from baseline tear film thickness at 4 and 12 weeks
Measurement of tear film thickness using OCT
次要结局
- Intraocular pressure (IOP)(Change from baseline IOP at 4 and 12 weeks)
- Ocular Surface Disease Index (OSDI)(Change from baseline OSDI at 4 and 12 weeks)
- Tear Break Up Time (BUT)(Change from baseline BUT at 4 and 12 weeks)
- Dry-Eye Related Quality of Life Score (DEQS)(Change from baseline DEQS at 4 and 12 weeks)
- Schirmer Test 1(Change from Schirmer Test 1 at 4 and 12 weeks)
- Tear film osmolarity(Change from baseline tear film osmolarity at 4 and 12 weeks)
- Corneal fluorescein staining(Change from baseline corneal fluorescein staining at 4 and 12 weeks)