Evaporative Dry Eye DiseaseNCT04521465
Safety and Efficacy of NovaTears® + Omega-3 (0.2%) Eye Drops on Signs and Symptoms of Dry Eye
An observational study of Evaporative Dry Eye Disease, run by Novaliq GmbH at 2 sites in Germany.
Trial summary
This PMCF study is carried out following successful CE marking of NovaTears® + Omega-3 and is intended to generate systematic clinical data on the safety and performance of the device when used in accordance with the intended purpose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Evaporative Dry Eye Disease
- What is being tested?
- NovaTears® + Omega-3 (Perfluorohexyloctane with 0.2% w/w Omega-3 fatty acid ethyl esters)
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 2 sitesGermany
- Study dates
- 9 Nov 2020to 17 Feb 2021
- Phase
- Observational
- 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
Study population: Patients with evaporative Dry Eye Disease
Who may be able to join
- Signed ICF (Informed Consent Form) and data protection form
- Patient-reported history of DED in both eyes
- Have an Ocular Surface Disease Index (OSD) score ≥ 25 at Visit 1
- Have Meibomian Gland Dysfunction (MGD) at Visit 1.
- Ability and willingness to follow instructions, including participation in all study assessments and visits
Who cannot join
- Women who are pregnant, nursing or planning a pregnancy
- Ocular surface pathology, clinically significant slit-lamp findings, abnormal lid anatomy, active ocular allergies
- Wear of contact lenses
- Known allergy or sensitivity to the medical device or its components
- Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 60 days before Visit 1.
- Clinical site employees or immediate family members of the same
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
NTO-001 Investigational Site
Heidelberg, 69121
NTO-001 Investigational Site
Nuremberg, 90403
About this study
Official title: A Multi-Center, Single Arm, Post-Market Clinical Follow-up Study to Evaluate the Safety and Efficacy of NovaTears® + Omega-3 (0.2%) Eye Drops on Signs and Symptoms of Dry Eye
This PMCF study is carried out following successful CE marking of NovaTears® + Omega-3 and is intended to generate systematic clinical data on the safety and performance of the device when used in accordance with the intended purpose.
- Conditions
- Evaporative Dry Eye Disease
- Being tested
- NovaTears® + Omega-3 (Perfluorohexyloctane with 0.2% w/w Omega-3 fatty acid ethyl esters)
- 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® + Omega-3 (Perfluorohexyloctane with 0.2% w/w Omega-3 fatty acid ethyl esters)Device
Eye drops
| Study group | Role | What they receive |
|---|---|---|
| NovaTears® + Omega-3 | Not described Receives: Device: NovaTears® + Omega-3 (Perfluorohexyloctane with 0.2% w/w Omega-3 fatty acid ethyl esters) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to confirm the performance, relieving symptoms and improving signs of DED, and to evaluate safety and tolerability of topical NovaTears® + Omega-3 (0.2%) eye drops, when used in accordance with its approved labeling
This PMCF study is intended to provide systematic clinical data supporting the safety and performance of the medical device NovaTears® + Omega-3 (0.2%).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start9 Nov 2020
- Primary completion17 Feb 2021
- Study completion17 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Evaporative 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novaliq GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sonja Kroesser, PhD, Study director, Novaliq GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521465
- Sponsor's protocol ID
- NTO-001
- Status last verified
- Apr 2021
- First submitted
- 19 Aug 2020
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jacobi C, Angstmann-Mehr S, Lange A, Kaercher T. A Water-Free Omega-3 Fatty Acid Eye Drop Formulation for the Treatment of Evaporative Dry Eye Disease: A Prospective, Multicenter Noninterventional Study. J Ocul Pharmacol Ther. 2022 Jun;38(5):348-353. doi: 10.1089/jop.2021.0102. Epub 2022 May 4.
PubMed 35507946
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Single Arm, Post-Market Clinical Follow-up Study to Evaluate the Safety and Efficacy of NovaTears® + Omega-3 (0.2%) Eye Drops on Signs and Symptoms of Dry Eye
- ClinicalTrials.gov ID
- NCT04521465
- Acronym / sponsor ID
- NTO-001
- Conditions
- Evaporative Dry Eye Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novaliq GmbHIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 17 Feb 2021 (actual)
- Study completion
- 17 Feb 2021 (actual)
- First posted
- 20 Aug 2020 (actual)
- 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.
This PMCF study is carried out following successful CE marking of NovaTears® + Omega-3 and is intended to generate systematic clinical data on the safety and performance of the device when used in accordance with the intended purpose.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NovaTears® + Omega-3 | – | Device: NovaTears® + Omega-3 (Perfluorohexyloctane with 0.2% w/w Omega-3 fatty acid ethyl esters) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with evaporative Dry Eye Disease
Key inclusion criteria (5 listed)
- Signed ICF (Informed Consent Form) and data protection form
- Patient-reported history of DED in both eyes
- Have an Ocular Surface Disease Index (OSD) score ≥ 25 at Visit 1
- Have Meibomian Gland Dysfunction (MGD) at Visit 1.
- Ability and willingness to follow instructions, including participation in all study assessments and visits
Key exclusion criteria (6 listed)
- Women who are pregnant, nursing or planning a pregnancy
- Ocular surface pathology, clinically significant slit-lamp findings, abnormal lid anatomy, active ocular allergies
- Wear of contact lenses
- Known allergy or sensitivity to the medical device or its components
- Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 60 days before Visit 1.
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® + Omega-3 (Perfluorohexyloctane with 0.2% w/w Omega-3 fatty acid ethyl esters)Eye drops | Device | NovaTears® + Omega-3 |
Primary outcome
The primary objective of this study is to confirm the performance, relieving symptoms and improving signs of DED, and to evaluate safety and tolerability of topical NovaTears® + Omega-3 (0.2%) eye drops, when used in accordance with its approved labeling
Time frame: 2 months
This PMCF study is intended to provide systematic clinical data supporting the safety and performance of the medical device NovaTears® + Omega-3 (0.2%).
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 15 Apr 2021.
- Derived from this study: PubMed 35507946Jacobi C, Angstmann-Mehr S, Lange A, Kaercher T. A Water-Free Omega-3 Fatty Acid Eye Drop Formulation for the Treatment of Evaporative Dry Eye Disease: A Prospective, Multicenter Noninterventional Study. J Ocul Pharmacol Ther. 2022 Jun;38(5):348-353. doi: 10.1089/jop.2021.0102. Epub 2022 May 4.
- Individual participant dataSharing planned: No
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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.
Sonja Kroesser, PhD study director
Novaliq GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaporative Dry Eye Disease, run by Novaliq GmbH at 2 sites in Germany.
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 5 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 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
The primary objective of this study is to confirm the performance, relieving symptoms and improving signs of DED, and to evaluate safety and tolerability of topical NovaTears® + Omega-3 (0.2%) eye drops, when used in accordance with its approved labeling (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04521465, which also lists 1 linked publication.
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 15 Apr 2021.