Influence of Perfluorohexyloctane (NovaTears) on Tear Film Thickness in Patients With Mild to Moderate Dry Eye Disease

Not Applicable

Completed

• Conditions: Dry Eye Disease
• Interventions: Device: NovaTears®; Device: Hydrabak®

• Registration Number: NCT03048526
• Lead Sponsor: Novaliq GmbH

Brief Summary

Patients with mild to moderate dry eye disease will be randomized to receive either NovaTears® or Hydrabak® eye drops as control.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-15
• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Primary Completion: 2017-04-18
• Study Completion: 2017-04-18
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-03
• Last Update Posted: 2017-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Men and women aged over 18 years
• History of dry eye disease for at least 3 months before the screening visit
• Be able and willing to follow instructions, including participation in all study assessments and visits
• Signed and dated written informed consent

Exclusion Criteria

• Have any clinically significant slit-lamp findings at the screening visit that may include trauma, Steven Johnson syndrome, and/or in the opinion of the investigator may interfere with study parameters
• Participation in a clinical trial in the 4 weeks preceding the before the screening visit
• Active ocular allergies or ocular allergies that are expected to be active during the study period
• Pregnancy, planned pregnancy or lactating
• Known hypersensitivity to any component of the study medication
• Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NovaTears®	NovaTears®	-
Hydrabak®	Hydrabak®	Unpreserved sodium chloride (0.9%) eye drops in ABAK® system

Primary Outcome Measures

Name	Time	Method
Tear film thickness as measured with high resolution optical coherence tomography	4 weeks

Secondary Outcome Measures

Name	Time	Method
Tear film break up time	4 weeks
Ocular surface disease index	4 weeks
Schirmer I test	4 weeks
Lipid layer thickness	4 weeks
Non-invasive tear break up time	4 weeks
Dynamic Meibomian Gland Imaging	4 weeks
Blink frequency	4 weeks
Symptom VAS	4 weeks
Corneal fluorescein staining	4 weeks
Conjunctival lissamine green staining	4 weeks

Trial Locations

Locations (1)

Medical University of Vienna, Department of Clinical Pharmacology; 🇦🇹 Vienna, Austria