Dry Eye DiseaseNCT02111928
NovaTears® Eye Drops Observational Study
An observational study of Dry Eye Disease, run by Novaliq GmbH at 2 sites in Germany.
Trial summary
This observational pilot-study is intended to collect outcome data from a cohort of 30 patients suffering from hyper-evaporative dry eye disease who are treated with the medical device NovaTears® eye drops for a duration of 5 to 7 weeks. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- NovaTears® Eye Drops
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 2 sitesGermany
- Study dates
- Dec 2013to May 2014
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mild to moderate hyper-evaporative dry eye disease
Who may be able to join
- According to NovaTears® instruction for use
- ≥ 18 years
- Patients with mild to moderate disease and hyper-evaporative dry eye disease applying eye lid hygiene for at least 14 days
- Ability and willingness to provide written Informed Consent
- Ability and willingness to participate in all examinations
- Willingness and ability to return for follow up visit
Who cannot join
- Patients with hypersensitivity to any of the components of NovaTears®
- Patients with contact lenses, pregnancies, or who are breast feeding
- Patients with non evaporate dry eye disease
- Patients taking lipid containing eye drops or requiring pharmacologic treatment of dry eye disease
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Zentrum fuer Augenheilkunde Uniklinik Koeln
Cologne, 50937
Praxis Dr. Kaercher
Heidelberg, 69121
About this study
Official title: NovaTears® Observational Study
This observational pilot-study is intended to collect outcome data from a cohort of 30 patients suffering from hyper-evaporative dry eye disease who are treated with the medical device NovaTears® eye drops for a duration of 5 to 7 weeks.
- Conditions
- Dry Eye Disease
- Being tested
- NovaTears® Eye Drops
- 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® Eye DropsDevice
Topical eye drops for lubrication of the ocular surface
| Study group | Role | What they receive |
|---|---|---|
| NovaTears® | Not described Receives: Device: NovaTears® Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy measured by routine ophthalmological assessment
Since this is a naturalistic medical device study under EU legislation, the primary outcome is the performance of the device in the intended indication, i.e. the performance claimed by the manufacturer in the instruction for use as determined by routine ophthalmologic assessments. For NovaTears the performance claimed is lubrication of the eye surface, stabilization of the tear film and relieve of symptoms associated with dry eye. These parameters are operationalized by multiple ophthalmological assessment which are part of routine ophthalmologic examinations including tear fluid volume as determined by the Schirmer I test, stability of the tear film as determined by Tear Film Break-Up Time and relieve of symptoms as determined by subjective patient symptom severity questionnaires and objective assessments of the corneal and conjunctival epithelia.
Measured: 5 to 7 weeks
Secondary outcomes (1)
Local Tolerability measured by ophthalmological assessment
Measured: 5 to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startDec 2013
- Primary completionMay 2014
- Study completionMay 2014
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novaliq GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Beckert, MD, Study director, Novaliq GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111928
- Sponsor's protocol ID
- NT-001
- Status last verified
- Oct 2015
- First submitted
- 7 Apr 2014
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NovaTears® Observational Study
- ClinicalTrials.gov ID
- NCT02111928
- Acronym / sponsor ID
- NT-001
- Conditions
- Dry Eye Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Novaliq GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 11 Apr 2014 (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.
This observational pilot-study is intended to collect outcome data from a cohort of 30 patients suffering from hyper-evaporative dry eye disease who are treated with the medical device NovaTears® eye drops for a duration of 5 to 7 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NovaTears® | – | Device: NovaTears® Eye Drops |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mild to moderate hyper-evaporative dry eye disease
Key inclusion criteria (6 listed)
- According to NovaTears® instruction for use
- ≥ 18 years
- Patients with mild to moderate disease and hyper-evaporative dry eye disease applying eye lid hygiene for at least 14 days
- Ability and willingness to provide written Informed Consent
- Ability and willingness to participate in all examinations
Key exclusion criteria (4 listed)
- Patients with hypersensitivity to any of the components of NovaTears®
- Patients with contact lenses, pregnancies, or who are breast feeding
- Patients with non evaporate dry eye disease
- Patients taking lipid containing eye drops or requiring pharmacologic treatment of dry eye disease
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® Eye DropsTopical eye drops for lubrication of the ocular surface | Device | NovaTears® |
Primary outcome
Efficacy measured by routine ophthalmological assessment
Time frame: 5 to 7 weeks
Since this is a naturalistic medical device study under EU legislation, the primary outcome is the performance of the device in the intended indication, i.e. the performance claimed by the manufacturer in the instruction for use as determined by routine ophthalmologic assessments. For NovaTears the performance claimed is lubrication of the eye surface, stabilization of the tear film and relieve of symptoms associated with dry eye. These parameters are operationalized by multiple ophthalmological assessment which are part of routine ophthalmologic examinations including tear fluid volume as determined by the Schirmer I test, stability of the tear film as determined by Tear Film Break-Up Time and relieve of symptoms as determined by subjective patient symptom severity questionnaires and objective assessments of the corneal and conjunctival epithelia.
1 secondary outcome
Local Tolerability measured by ophthalmological assessment
Time frame: 5 to 7 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 6 Oct 2015.
Related trials for Dry Eye Disease
Not yet recruiting
LacriFill Canalicular Occlusion for Dry Eye After LASIK
Dry Eye Syndrome
Active, not recruitingPhase 3
Nipocalimab in Moderate to Severe Sjogren's Disease
Sjogrens Syndrome
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Not yet recruitingEarly Phase 1
a Novel siRNA Eyedrops for DED Treatment
Dry Eye
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.
Michael Beckert, MD 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 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 6 inclusion and 4 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 6 Oct 2015. 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?
Efficacy measured by routine ophthalmological assessment (time frame: 5 to 7 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 6 Oct 2015.