Dry Eye DiseaseNCT03048526
Influence of Perfluorohexyloctane (NovaTears) on Tear Film Thickness in Patients With Mild to Moderate Dry Eye Disease
A study testing NovaTears® and Hydrabak® in people with Dry Eye Disease, run by Novaliq GmbH at 1 site in Austria.
Trial summary
Patients with mild to moderate dry eye disease will be randomized to receive either NovaTears® or Hydrabak® eye drops as control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- NovaTears® and Hydrabak®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- 15 Dec 2016to 18 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, A-1090
About this study
Patients with mild to moderate dry eye disease will be randomized to receive either NovaTears® or Hydrabak® eye drops as control.
- Conditions
- Dry Eye Disease
- Being tested
- NovaTears®, Hydrabak®
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovaTears®Device
Topical eye drops for lubrication of the ocular surface
Hydrabak®Device
Eye drops
| Study group | Role | What they receive |
|---|---|---|
| NovaTears® | Experimental | Not described Receives: Device: NovaTears® |
| Hydrabak® | Active comparator | Unpreserved sodium chloride (0.9%) eye drops in ABAK® system Receives: Device: Hydrabak® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear film thickness as measured with high resolution optical coherence tomography
Measured: 4 weeks
Secondary outcomes (10)
Lipid layer thickness
Measured: 4 weeks
Non-invasive tear break up time
Measured: 4 weeks
Dynamic Meibomian Gland Imaging
Measured: 4 weeks
Blink frequency
Measured: 4 weeks
Symptom VAS
Measured: 4 weeks
Corneal fluorescein staining
Measured: 4 weeks
Conjunctival lissamine green staining
Measured: 4 weeks
Schirmer I test
Measured: 4 weeks
Tear film break up time
Measured: 4 weeks
Ocular surface disease index
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start15 Dec 2016
- Primary completion18 Apr 2017
- Study completion18 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novaliq GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerhard Garhoefer, MD, Study director, Novaliq GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048526
- Sponsor's protocol ID
- NT-004
- Status last verified
- Jul 2017
- First submitted
- 7 Feb 2017
- Last updated
- 5 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Perfluorohexyloctane (NovaTears) on Tear Film Thickness in Patients With Mild to Moderate Dry Eye Disease
- ClinicalTrials.gov ID
- NCT03048526
- Acronym / sponsor ID
- NT-004
- Conditions
- Dry Eye Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Novaliq GmbHIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 18 Apr 2017 (actual)
- Study completion
- 18 Apr 2017 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with mild to moderate dry eye disease will be randomized to receive either NovaTears® or Hydrabak® eye drops as control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NovaTears® | Experimental | Device: NovaTears® |
| Hydrabak® | Active comparator | Device: Hydrabak®Unpreserved sodium chloride (0.9%) eye drops in ABAK® system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NovaTears®Topical eye drops for lubrication of the ocular surface | Device | NovaTears® |
| Hydrabak®Eye drops | Device | Hydrabak® |
Primary outcome
Tear film thickness as measured with high resolution optical coherence tomography
Time frame: 4 weeks
10 secondary outcomes
Lipid layer thickness
Time frame: 4 weeks
Non-invasive tear break up time
Time frame: 4 weeks
Dynamic Meibomian Gland Imaging
Time frame: 4 weeks
Blink frequency
Time frame: 4 weeks
Symptom VAS
Time frame: 4 weeks
Corneal fluorescein staining
Time frame: 4 weeks
Conjunctival lissamine green staining
Time frame: 4 weeks
Schirmer I test
Time frame: 4 weeks
Tear film break up time
Time frame: 4 weeks
Ocular surface disease index
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
Related trials for Dry Eye Disease
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Garhoefer, MD study director
Novaliq GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NovaTears® and Hydrabak® in people with Dry Eye Disease, run by Novaliq GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear film thickness as measured with high resolution optical coherence tomography (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2017.