NovaTears® Eye Drops Observational Study NT-002
NovaTears® Observational Study NT-002
1 other identifier
observational
72
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2015
Shorter than P25 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 21, 2015
CompletedFirst Posted
Study publicly available on registry
February 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 9, 2016
March 1, 2016
11 months
January 21, 2015
March 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Subjective symptom severity
Change in subjective symptom severity score compared to Baseline
6 to 8 weeks
Secondary Outcomes (1)
Tear-Film Break-up Time
6 to 8 weeks
Study Arms (1)
NovaTears®
Interventions
Eligibility Criteria
Patients with dry eye disease due to meibomian gland dysfunction
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novaliq GmbHlead
Study Sites (8)
Prof. Dr. Norbert Schrage
Cologne, 50765, Germany
University Eye Hospital of the HHU Duesseldorf
Düsseldorf, 40225, Germany
University Eye Hospital of the FAU Erlangen-Nuremberg
Erlangen, 91054, Germany
University Eye Hospital Heidelberg
Heidelberg, 69120, Germany
Dr. Thomas Kaercher
Heidelberg, 69121, Germany
JenVis Research Institute
Jena, 07745, Germany
Staedtisches Klinikum Karlsruhe
Karlsruhe, 76133, Germany
University Eye Hospital, LMU Munich
Munich, 80336, Germany
Related Publications (1)
Steven P, Augustin AJ, Geerling G, Kaercher T, Kretz F, Kunert K, Menzel-Severing J, Schrage N, Schrems W, Krosser S, Beckert M, Messmer EM. Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease Due to Meibomian Gland Disease. J Ocul Pharmacol Ther. 2017 Nov;33(9):678-685. doi: 10.1089/jop.2017.0042. Epub 2017 Sep 18.
PMID: 28922088DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novaliq GmbH
Novaliq GmbH
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2015
First Posted
February 5, 2015
Study Start
January 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
March 9, 2016
Record last verified: 2016-03