Back to resultsInfluence of Perfluorohexyloctane (NovaTears) on Tear Film Thickness in Patients With Mild to Moderate Dry Eye Disease
Primary Purpose
Dry Eye Disease
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
NovaTears®
Hydrabak®
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease
Eligibility Criteria
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
Sites / Locations
- Medical University of Vienna, Department of Clinical Pharmacology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NovaTears®
Hydrabak®
Arm Description
Unpreserved sodium chloride (0.9%) eye drops in ABAK® system
Outcomes
Primary Outcome Measures
Tear film thickness as measured with high resolution optical coherence tomography
Secondary Outcome Measures
Lipid layer thickness
Non-invasive tear break up time
Dynamic Meibomian Gland Imaging
Blink frequency
Symptom VAS
Corneal fluorescein staining
Conjunctival lissamine green staining
Schirmer I test
Tear film break up time
Ocular surface disease index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03048526
Brief Title
Influence of Perfluorohexyloctane (NovaTears) on Tear Film Thickness in Patients With Mild to Moderate Dry Eye Disease
Official Title
Influence of Perfluorohexyloctane (NovaTears) on Tear Film Thickness in Patients With Mild to Moderate Dry Eye Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 15, 2016 (Actual)
Primary Completion Date
April 18, 2017 (Actual)
Study Completion Date
April 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novaliq GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Patients with mild to moderate dry eye disease will be randomized to receive either NovaTears® or Hydrabak® eye drops as control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NovaTears®
Arm Type
Experimental
Arm Title
Hydrabak®
Arm Type
Active Comparator
Arm Description
Unpreserved sodium chloride (0.9%) eye drops in ABAK® system
Intervention Type
Device
Intervention Name(s)
NovaTears®
Intervention Description
Topical eye drops for lubrication of the ocular surface
Intervention Type
Device
Intervention Name(s)
Hydrabak®
Intervention Description
Eye drops
Primary Outcome Measure Information:
Title
Tear film thickness as measured with high resolution optical coherence tomography
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Lipid layer thickness
Time Frame
4 weeks
Title
Non-invasive tear break up time
Time Frame
4 weeks
Title
Dynamic Meibomian Gland Imaging
Time Frame
4 weeks
Title
Blink frequency
Time Frame
4 weeks
Title
Symptom VAS
Time Frame
4 weeks
Title
Corneal fluorescein staining
Time Frame
4 weeks
Title
Conjunctival lissamine green staining
Time Frame
4 weeks
Title
Schirmer I test
Time Frame
4 weeks
Title
Tear film break up time
Time Frame
4 weeks
Title
Ocular surface disease index
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Garhoefer, MD
Organizational Affiliation
Novaliq GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Medical University of Vienna, Department of Clinical Pharmacology
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Influence of Perfluorohexyloctane (NovaTears) on Tear Film Thickness in Patients With Mild to Moderate Dry Eye Disease
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