Difference in the Frequency of Use of Lachrymal Substitutes in Patients With Moderate to Severe Dry Eye Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day (patient diary)
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. Relief of symptoms in patients with moderate to severe dry eye disease is usually reached by the use of artificial tears during the day. Nighttime relief is often achieved by substances known to be more adhesive to the ocular surface, such as gels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •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 administered medical device product, fluorescein or lissamine green
- •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, hematological 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 sterilized.
- •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.
研究组 & 干预措施
Experimental: Patients with dry eye syndrome 1
20 patients with dry eye syndrome, they will receive intervention 1 for one week and then cross over to intervention 2
干预措施: Thealoz Duo eye drops and Thealoz Duo gel (Device)
Experimental: Patients with dry eye syndrome 1
20 patients with dry eye syndrome, they will receive intervention 1 for one week and then cross over to intervention 2
干预措施: Thealoz Duo gel (Device)
Experimental: Patients with dry eye syndrome 2
20 patients with dry eye syndrome, they will receive intervention 2 for one week and then cross over to intervention 1
干预措施: Thealoz Duo eye drops and Thealoz Duo gel (Device)
Experimental: Patients with dry eye syndrome 2
20 patients with dry eye syndrome, they will receive intervention 2 for one week and then cross over to intervention 1
干预措施: Thealoz Duo gel (Device)
结局指标
主要结局
Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day (patient diary)
时间窗: 4 weeks
Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day during the observation period of one week for each medical device (patient diary)
次要结局
- Conjunctival and corneal staining(4 weeks)
- Tear Break Up Time (BUT)(4 weeks)
- Schirmer I test(4 weeks)
- OSDI questionnaire(4 weeks)
- Quality of life of patients (VAS)(4 weeks)
研究者
Gerhard Garhofer
Assoc. Prof. PD Dr.
Medical University of Vienna