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

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03048526
• Other study ID #: NT-004
• Status: Completed
• Phase: N/A
• First received: February 7, 2017
• Last updated: July 3, 2017
• Start date: December 15, 2016
• Est. completion date: April 18, 2017

Study information

• Verified date: July 2017
• Source: Novaliq GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 18, 2017
• Est. primary completion date: April 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Device:
• NovaTears®
Topical eye drops for lubrication of the ocular surface
• Hydrabak®
Eye drops

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Novaliq GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear film thickness as measured with high resolution optical coherence tomography		4 weeks
Secondary	Lipid layer thickness		4 weeks
Secondary	Non-invasive tear break up time		4 weeks
Secondary	Dynamic Meibomian Gland Imaging		4 weeks
Secondary	Blink frequency		4 weeks
Secondary	Symptom VAS		4 weeks
Secondary	Corneal fluorescein staining		4 weeks
Secondary	Conjunctival lissamine green staining		4 weeks
Secondary	Schirmer I test		4 weeks
Secondary	Tear film break up time		4 weeks
Secondary	Ocular surface disease index		4 weeks