Dry Eye SyndromesNCT02356328
NovaTears® Eye Drops Observational Study NT-003
An observational study of Dry Eye Syndromes, run by Novaliq GmbH at 2 sites in Germany.
Trial summary
This observational study is intended to collect outcome data from a cohort of 30 patients suffering from dry eye disease due to chronic ocular Graft-versus-Host Disease (GvHD) who are treated with the medical device NovaTears® eye drops for a duration of 11 to 13 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- NovaTears® Eye Drops
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2015to Jan 2016
- 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 dry eye disease due to chronic ocular GvHD
Who may be able to join
- According to NovaTears® instruction for use
- ≥ 18 years
- Patients after an allogeneic hematopoietic stem cell transplantation with dry eye disease due to chronic ocular Graft-versus-Host Disease
- 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 known hypersensitivity to any of the components of NovaTears®
- Patients with contact lenses, pregnancies, or who are breast feeding
- Patients with dry eye disease caused by any other known underlying systemic disease
- Patients planning an ophthalmologic surgical procedure during the course of this PMCF study
- Patients using lipid-containing or tear-film stabilizing eye drops/sprays except cyclosporin formulations
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Department of Ophthalmology, University of Cologne
Cologne, 50937
University Eye Hospital Freiburg
Freiburg im Breisgau, 79106
About this study
Official title: NovaTears® Observational Study NT-003
This observational study is intended to collect outcome data from a cohort of 30 patients suffering from dry eye disease due to chronic ocular Graft-versus-Host Disease (GvHD) who are treated with the medical device NovaTears® eye drops for a duration of 11 to 13 weeks.
- Conditions
- Dry Eye Syndromes
- 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.
Subjective symptom severity
Change in subjective symptom severity score compared to Baseline
Measured: 11-13 weeks
Secondary outcomes (1)
Tear-Film Break-up Time
Change in Tear Film Break-up Time (measured in seconds) compared to Baseline
Measured: 11 to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novaliq GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novaliq GmbH, Study director, Novaliq GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356328
- Sponsor's protocol ID
- NT-003
- Status last verified
- Mar 2016
- First submitted
- 21 Jan 2015
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NovaTears® Observational Study NT-003
- ClinicalTrials.gov ID
- NCT02356328
- Acronym / sponsor ID
- NT-003
- Conditions
- Dry Eye Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Novaliq GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 5 Feb 2015 (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 study is intended to collect outcome data from a cohort of 30 patients suffering from dry eye disease due to chronic ocular Graft-versus-Host Disease (GvHD) who are treated with the medical device NovaTears® eye drops for a duration of 11 to 13 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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with dry eye disease due to chronic ocular GvHD
Key inclusion criteria (6 listed)
- According to NovaTears® instruction for use
- ≥ 18 years
- Patients after an allogeneic hematopoietic stem cell transplantation with dry eye disease due to chronic ocular Graft-versus-Host Disease
- Ability and willingness to provide written Informed Consent
- Ability and willingness to participate in all examinations
Key exclusion criteria (5 listed)
- Patients with known hypersensitivity to any of the components of NovaTears®
- Patients with contact lenses, pregnancies, or who are breast feeding
- Patients with dry eye disease caused by any other known underlying systemic disease
- Patients planning an ophthalmologic surgical procedure during the course of this PMCF study
- Patients using lipid-containing or tear-film stabilizing eye drops/sprays except cyclosporin formulations
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
Subjective symptom severity
Time frame: 11-13 weeks
Change in subjective symptom severity score compared to Baseline
1 secondary outcome
Tear-Film Break-up Time
Time frame: 11 to 13 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 9 Mar 2016.
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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.
Novaliq GmbH 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 Syndromes, 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 5 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 9 Mar 2016. 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?
Subjective symptom severity (time frame: 11-13 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 9 Mar 2016.