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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Device: NovaTears®; Device: Hydrabak®

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, A-1090
    • Medical University of Vienna, Department of Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NovaTears®	Device: NovaTears®; Topical eye drops for lubrication of the ocular surface
Active Comparator: Hydrabak®; Unpreserved sodium chloride (0.9%) eye drops in ABAK® system	Device: Hydrabak®; Eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tear film thickness as measured with high resolution optical coherence tomography	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Tear film break up time	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
Schirmer I test	4 weeks
Ocular surface disease index	4 weeks

Collaborators and Investigators

• Sponsor: Novaliq GmbH
• Investigators: Study Director: Gerhard Garhoefer, MD, Novaliq GmbH

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2016
• Primary Completion (Actual): April 18, 2017
• Study Completion (Actual): April 18, 2017

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2017
• Last Update Submitted That Met QC Criteria: July 3, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: NT-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No