Influence of Three Different Formulations of Lachrymal Substitutes on Tear Film Thickness and Other Signs and Symptoms in Patients With Moderate to Severe Dry Eye Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in tear film thickness as measured with Optical Coherence Tomography (OCT)
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, exact information about influence on tear film thickness and 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 ultra-high resolution optical coherence tomography (OCT) has become available. The aim of the present study is to assess the influence on tear film thickness of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Optive® Eye Drops and Systane Ultra® Eye Drops in patients with moderate to severe dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test, corneal fluorescein staining and determination of tear break up time (BUT) will be performed to compare the product effects.
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
- Single (Investigator)
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
- •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
- •Presence of an ocular pathology judged by the investigator as incompatible with the study.
- •Any other clinical relevant ocular abnormality except DES.
- •History of allergy, known hypersensitivity to one of the components: the study medications or Fluorescein.
- •History of known clinically relevant allergy.
- •Medical or surgical history judged by the investigator to be incompatible with the study participation (hepatic or renal insufficiency; all chronic severe organic disease: metabolic, endocrine, neoplasic, haematological disease; severe psychiatric illness, etc.).
- •History of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (Day 0).
- •Pregnancy, lactation.
- •Pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilised.
- •Participation in any high-speed or water-sports during the study without ocular protection (goggles or glasses).
- •Subject unable to understand the study instructions or unlikely to comply with the study schedule and treatment.
- •Participation in another clinical study in the 4 weeks before the start of the present study or at the same time as the present study.
- •Subject is a ward of court.
结局指标
主要结局
Change in tear film thickness as measured with Optical Coherence Tomography (OCT)
时间窗: 10 weeks; at baseline, 10 minutes, 20 minutes, 40 minutes, 60 minutes, 120 minutes and 240 minutes after instillation of eye drops as well as 4 weeks and 8 weeks after the first instillation
Tear film thickness as measured with Optical Coherence Tomography (OCT) predose and at defined time points after the first instillation, as well as on each study day
次要结局
- Subjective evaluation of ocular comfort with questionnaire(10 weeks)
- Corneal fluorescein staining (Oxford grading scale)(10 weeks)
- Tear Break Up Time (BUT)(10 weeks)
- Schirmer I test(10 weeks)
- OSDI score(10 weeks)
- Efficacy assessment of eye drops by the patient with questionnaire(10 weeks)
- Conjunctival hyperemia score(10 weeks)
- Efficacy assessment of eye drops by the investigator with questionnaire(10 weeks)
研究者
Gerhard Garhofer
Assoc. Prof. PD Dr.
Medical University of Vienna