Assessment of Tear Film Thickness by Optical Coherence Tomography in Healthy Subjects and Subjects With Dry Eye Disease
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Tear film thickness
研究概览
简要总结
Dry eye syndrome (DES) is a highly prevalent ocular condition with severe consequences for the patients reaching from ocular discomfort in its simplest form up to visual impairment and corneal ulceration in severe cases. Data from epidemiological studies indicate that DES is a common disease, especially in the elderly population, affecting up to 20% of adults aged 45 years or older. Topical lubricants are a mainstay of therapy, but data on its effect on tear film thickness and the corneal residence time are lacking.
Recently, a new objective method for assessment of tear film thickness by optical coherence tomography has been developed. The present study aims to investigate the corneal residence time of an established topical lubricant compared to placebo in patients with DES and healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Inclusion criteria for healthy subjects:
- •Men and women aged over 18 years
- •Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- •Normal ophthalmic findings, ametropia < 6 Dpt
- •Schirmer I test > 10 mm and BUT > 10 sec
- •Inclusion criteria for patients with dry eye syndrome:
- •Men and women aged over 18 years
- •Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant except DES
- •Normal ophthalmic findings, ametropia < 6 Dpt
- •History of dry eye syndrome for at least 3 months
- •Tear Break Up Time (BUT) < 10 seconds or Schirmer I test < 7 mm
- •At least 2 symptoms of dry eye syndrome (foreign body sensation, burning, photophobia, blurred vision, pain, itching)
- •Normal ophthalmic findings except dry eye syndrome
排除标准
- •Regular use of medication (except contraceptives), abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- •Treatment in the previous 3 weeks with any drug
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •Ametropia >= 6 Dpt
- •Pregnancy
- •Difference of more than 3 mm in Schirmer I test or difference of > 3 sec in BUT between the two eyes
- •Known medical history of allergy, hypersensitivity or poor tolerance to any components of the medication or medical product used in the study
研究组 & 干预措施
30 healthy subjects
Subjects will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo
干预措施: GENTEAL HA® Eye Drops (NOVARTIS, Switzerland) (Device)
30 healthy subjects
Subjects will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo
干预措施: Physiological Sodium Chloride solution (0,9%) (Other)
30 patients with dry eye syndrome
Patients will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo
干预措施: GENTEAL HA® Eye Drops (NOVARTIS, Switzerland) (Device)
30 patients with dry eye syndrome
Patients will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo
干预措施: Physiological Sodium Chloride solution (0,9%) (Other)
结局指标
主要结局
Tear film thickness
时间窗: change from baseline to 1 hour after administration
次要结局
- Ocular Surface Disease Index(1 day)
- Schirmer I Test(1 day)
- Tear Break Up Time(1 day)
研究者
Gerhard Garhofer
Assoc. Prof. PD Dr.
Medical University of Vienna