NovaTears® Eye Drops Observational Study NT-003 | NCT02356328

Studies
NovaTears® Eye Drops Observational Study NT-003

NCT02356328

Sponsor

Novaliq GmbH

Status

Completed

Last Update Posted

Mar 9, 2016Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Dry Eye Syndromes

Interventions

NovaTears® Eye Drops

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Jan 21, 2015

First Submission Date that Met QC Criteria

Feb 1, 2015

First Posted Date

Feb 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2016

Last Update Posted Date

Mar 9, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NovaTears®			Device: NovaTears® Eye Drops

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NovaTears® Eye Drops	Device	Topical eye drops for lubrication of the ocular surface	NovaTears®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subjective symptom severity	Change in subjective symptom severity score compared to Baseline	11-13 weeks

Secondary Outcomes

Measure	Description	Time Frame
Tear-Film Break-up Time	Change in Tear Film Break-up Time (measured in seconds) compared to Baseline	11 to 13 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with dry eye disease due to chronic ocular GvHD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novaliq GmbH	Novaliq GmbH	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, University of Cologne		Cologne		50937	Germany
University Eye Hospital Freiburg

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided