NCT02356328

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

January 21, 2015

Last Update Submit

March 8, 2016

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

  • Subjective symptom severity

    Change in subjective symptom severity score compared to Baseline

    11-13 weeks

Secondary Outcomes (1)

  • Tear-Film Break-up Time

    11 to 13 weeks

Study Arms (1)

NovaTears®

Device: NovaTears® Eye Drops

Interventions

NovaTears® Eye DropsDEVICE

Topical eye drops for lubrication of the ocular surface

NovaTears®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with dry eye disease due to chronic ocular GvHD

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Ophthalmology, University of Cologne

Cologne, 50937, Germany

Location

University Eye Hospital Freiburg

Freiburg im Breisgau, 79106, Germany

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Novaliq GmbH

    Novaliq GmbH

    STUDY DIRECTOR

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

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 9, 2016

Record last verified: 2016-03

Locations

DE(2)