- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02356341
NovaTears® Eye Drops Observational Study NT-002
March 8, 2016 updated by: Novaliq GmbH
NovaTears® Observational Study NT-002
This observational study is intended to collect outcome data from a cohort of 90 patients suffering from symptoms of dry eye disease due to meibomian gland dysfunction who are treated with the medical device NovaTears® eye drops for a duration of 6 to 8 weeks.
Study Overview
Study Type
Observational
Enrollment (Actual)
72
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cologne, Germany, 50765
- Prof. Dr. Norbert Schrage
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Duesseldorf, Germany, 40225
- University Eye Hospital of the HHU Duesseldorf
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Erlangen, Germany, 91054
- University Eye Hospital of the FAU Erlangen-Nuremberg
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Heidelberg, Germany, 69120
- University Eye Hospital Heidelberg
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Heidelberg, Germany, 69121
- Dr. Thomas Kaercher
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Jena, Germany, 07745
- JenVis Research Institute
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Karlsruhe, Germany, 76133
- Staedtisches Klinikum Karlsruhe
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Munich, Germany, 80336
- University Eye Hospital, LMU Munich
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with dry eye disease due to meibomian gland dysfunction
Description
Inclusion Criteria:
- According to NovaTears® instruction for use
- ≥ 18 years
- Patients with dry eye disease due to meibomian gland dysfunction 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
Exclusion Criteria:
- Patients with hypersensitivity to any of the components of NovaTears®
- Patients with contact lenses, pregnancies, or who are breast feeding
- Patients with dry eye disease not caused by meibomian gland dysfunction
- Patients taking lipid containing eye drops or requiring topical pharmacological treatment of dry eye disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
NovaTears®
|
Topical eye drops for lubrication of the ocular surface
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective symptom severity
Time Frame: 6 to 8 weeks
|
Change in subjective symptom severity score compared to Baseline
|
6 to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tear-Film Break-up Time
Time Frame: 6 to 8 weeks
|
Change in Tear Film Break-up Time (measured in seconds) compared to Baseline
|
6 to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Novaliq GmbH, Novaliq GmbH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
January 21, 2015
First Submitted That Met QC Criteria
February 1, 2015
First Posted (Estimate)
February 5, 2015
Study Record Updates
Last Update Posted (Estimate)
March 9, 2016
Last Update Submitted That Met QC Criteria
March 8, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NT-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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