NovaTears® Eye Drops Observational Study
NovaTears® Observational Study
1 other identifier
observational
30
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2013
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 7, 2014
CompletedFirst Posted
Study publicly available on registry
April 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedOctober 6, 2015
October 1, 2015
5 months
April 7, 2014
October 5, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
5 to 7 weeks
Secondary Outcomes (1)
Local Tolerability measured by ophthalmological assessment
5 to 7 weeks
Study Arms (1)
NovaTears®
Interventions
Eligibility Criteria
Patients with mild to moderate hyper-evaporative dry eye disease
You may qualify if:
- 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
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 non evaporate dry eye disease
- Patients taking lipid containing eye drops or requiring pharmacologic treatment of dry eye disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novaliq GmbHlead
Study Sites (2)
Zentrum fuer Augenheilkunde Uniklinik Koeln
Cologne, 50937, Germany
Praxis Dr. Kaercher
Heidelberg, 69121, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Beckert, MD
Novaliq GmbH
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2014
First Posted
April 11, 2014
Study Start
December 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
October 6, 2015
Record last verified: 2015-10