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The influence of a mineral oil cationic nanoemulsion or perfluorohexyloctane on the tear film lipid layer and higher order aberrations

The influence of a mineral oil cationic nanoemulsion or perfluorohexyloctane on the tear film lipid layer and higher order aberrations

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00028696
Enrollment
113
Registered
2022-04-25
Start date
2018-01-01
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

H04.1

Interventions

Group 1: short term effect - CN (cationic nanoemulsion) Cationorm®
Santen Pharmaceutical, Munich, Germany Once a single drop Group 2: short term effect - F6H8 (perfluorohexyloctane - semifluorinated alkanes) Evotears®, Ursapharm Arzneimittel GmbH, Saarbrücken, Germa
Santen Pharmaceutical, Munich, Germany One drop each 5 times a day for 12 weeks Group 5: long term effect - F6H8 (perfluorohexyloctane - semifluorinated alkanes) Evotears®, Ursapharm Arzneimittel Gmb

Sponsors

Heinrich-Heine-Universität Düsseldorf
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - lipid layer deficit, defined as less than 75 interferometric color units (ICU) [measured with the LipiView® interferometer] - pathological Ocular Surface Disease Index (OSDI) of 13 or higher

Exclusion criteria

Exclusion criteria: - LLT of more than 75 ICU - OSDI lower than 13 - application of any other eyedrops during the study period - presence of any other previously diagnosed chronic ocular surface disease (e. g. perennial allergic conjunctivitis) and/or recent ocular surgery

Design outcomes

Primary

MeasureTime frame
short term group: 120 min after application long term group: 12 week after application

Countries

Germany

Contacts

Public ContactAndreas Frings

Heinrich-Heine-Universität Düsseldorf

Andreas.Frings@med.uni-duesseldorf.de+49 911 235 558 25

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 10, 2026