Observation of tear film break-up time using the Dry Eye Monitor (KOWA DR-1 a) using EvoTears® eye drops compared to eye drops containing lipids: a monocentric, prospective, randomized open clinical study

RSAPHARM Arzneimittel GmbH0 个研究点目标入组 30 人开始时间: 2020年11月2日最近更新: 2022年1月17日

适应症

试验速览

•1. Male and female patients aged > 18 years
•2. Patients with evaporative dry eye and mild to moderate meibomian gland dysfunction:
•2.1. Hyposecretion and reduced manual expression of meibomian glands
•2.2. NIBUT = 10 s
•2.3. Staining of the ocular surface: = 4 and = 9 points on the Oxford grading scale (15 points max)
•3. Subjective feeling of evaporative dry eye discomfort more than 3 months
•3.1. Visual analogue scale (VAS) = 2/10
•3.2. OSDI = 15
•4. Stable therapy (topical and systemic) = 4 weeks
•5. Patient willing and being able to fulfil the requirements of the trial protocol

•1. Dry eye due to systemic disease, concomitant medication, malign conditions or idiopathic causes
•2. History of ocular surgery during the past 3 months
•3. Malposition of the lids and/or lagophthalmos
•4. Punctum plugs during the past 3 months
•5. Contact lens wearers
•6. Use of lipid-containing eye drops during the past 3 months
•7. Use of other therapeutic ophthalmics during the past 3 months
•8. Sensitivity against any of the ingredients
•9. Patient pregnant or breastfeeding
•10. Women with childbearing potential without regular and correct use of contraception with an error rate < 1% (e.g. sexual abstinence, estrogen and gestagen containing contraceptives, vasectomy, intrauterine pessary with hormones)
•11. Concomitant clinical trial participation within the last 4 weeks
•12. Earlier participation at this clinical trial or the patient being an investigator or a member of the personnel involved at this clinical trial
•13. Inability to understand written patient information

发起方

RSAPHARM Arzneimittel GmbH