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

Efficacy of phospholipid and soy lecithin eye sprays on tear film stability and subjective comfort. A prospective study according to §23.b MPG. - inno_0116

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011019

Enrollment

200

Registered

2016-09-06

Start date

2016-09-05

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H04

Interventions

Group 1: Randomized application of Ocuvers-H in one eye and Tears Again in the fellow eye. Group 2: Randomized application of Ocuvers-L in one eye and Tears Again in the fellow eye. Group 3: Randomize

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
tear film break-uip time 10 min and 30 min after application of the eye spray	—

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactDaniel Angerer

innomedis AG

da@innomedis.com0221-46757446

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026