Efficacy of phospholipid and soy lecithin eye sprays on tear film stability and subjective comfort. A prospective study according to §23.b MPG.

Not Applicable

• Conditions: H04; Disorders of lacrimal system

• Registration Number: DRKS00011019
• Lead Sponsor: innomedis AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-06
• Study Completion: 2016-10-24
• Results First Posted: 2017-05-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Patients with an age from 18 to 90 years;
severity of dry eye 1, 2, 3 or 4 (according to [Dry Eye Workshop] DEWS 2007);
Written patient informed consent

Exclusion Criteria

Application of artificial tears or ocular medication on the day of examination;
Patients with degenerative ocular pathologies;
Pateints with ocular inflammation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
tear film break-uip time 10 min and 30 min after application of the eye spray

Secondary Outcome Measures

Name	Time	Method
The following paramters will be assessed 10 min and 30 min after application of the eye spray:<br>Subjective assessment of comfort;<br>assessment of smell;<br>automatic classification of hyperemia grade; Meibography of upper and lower lid;<br>Lid-parallel conjunctival ocular folds (LIPCOF);<br>height of tear meniscus;<br>lipid layer thickness;<br>adverse events<br><br>The Ocular Surface Disease Index (OSDI) will be assessed only 30 min after application of the eye spray.