Influence of Lachrymal Substitutes on Tear Film Thickness in Patients With Moderate Dry Eye Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Tear film thickness
研究概览
简要总结
Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population. Topically administered lubricants are the basis for treatment of this disease. However, information about the corneal residence time of topical lubricants is still sparse, therefore no ideal treatment regimen has been found.
Recently a new method for assessment of tear film thickness based on optical coherence tomography (OCT) has become available. The aim of the present study is to assess corneal residence time of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Hyabak® Eye Drops and Hydrabak® Eye Drops in patients with moderate dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test and determination of tear break up time (BUT) will be performed..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Signed and dated written informed consent.
- •History of dry eye syndrome for at least 3 months
- •Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm
- •OSDI (Ocular Surface Disease Index) ≤ 32 and ≥ 13
- •Normal ophthalmic findings except dry eye syndrome, ametropia < 6 Dpt.
- •No administration of topical lubricants 24 hours before the screening examination
排除标准
- •Participation in a clinical trial in the 3 weeks preceding the study
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •Presence or history of a severe medical condition as judged by the clinical investigator
- •Intake of parasympathomimetic or anti-psychotic drugs
- •Wearing of contact lenses
- •Treatment with corticosteroids in the 4 weeks preceding the study
- •Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks preceding the study
- •Ocular infection or clinically significant inflammation
- •Ocular surgery in the 3 months preceding the study
- •Sjögren's syndrome
- •Stevens-Johnson syndrome
- •History of allergic conjunctivitis
- •Ametropia >= 6 Dpt
- •Pregnancy, planned pregnancy or lactating
- •Known hypersensitivity to any component of the study medication.
- •Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease
- •Inability to understand the study procedures
研究组 & 干预措施
Dry Eye Syndrome I
20 patients with moderate dry eye syndrome
干预措施: Thealoz Duo® (Device)
Dry Eye Syndrome II
20 patients with moderate dry eye syndrome
干预措施: Hyabak® (Device)
Dry Eye Syndrome III
20 patients with moderate dry eye syndrome
干预措施: Hydrabak® (Device)
结局指标
主要结局
Tear film thickness
时间窗: Change in tear film thickness from predose to 10 ± 3 minutes, 20 ± 3 minutes, 40 ± 5 minutes, 60 ± 5 minutes, 120 ± 10 minutes and 240 ± 10 minutes after instillation
Change in tear film thickness as measured with OCT. Total time frame is 4 hours
次要结局
- Tear Break Up Time(change from screening to the last OCT measurement)
- Subjective evaluation of ocular comfort(change after instillation and after the last OCT measurement)
- Visual Acuity(change from screening to after the last OCT measurement)
- Schirmer I test(change from screening to after the last OCT measurement)
- Intraocular Pressure(change from screening to after the last OCT measurement)
研究者
Gerhard Garhofer
Assoc. Prof. PD Dr.
Medical University of Vienna