Observation of tear film break-up time in patients with evaporative dry eye symptoms using EvoTears® eye drops compared to eye drops containing lipids

Not Applicable

Completed

• Conditions: Evaporative dry eye and meibomian gland dysfunction; Eye Diseases; Other disorders of lacrimal gland

• Registration Number: ISRCTN15512057
• Lead Sponsor: RSAPHARM Arzneimittel GmbH

Brief Summary

2021 Results article in https://www.ecronicon.com/ecop/ECOP-12-00775.php (added 07/01/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-03-06
• Study Start: 2020-11-02
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
on-invasive Tear Break Up Time (NIBUT) measured using Dry Eye Monitor (KOWA DR-1 a) at day 1, day 7 ±2 and day 28 ±2