NovaTears® Eye Drops Observational Study NT-003

March 8, 2016 updated by: Novaliq GmbH

NovaTears® Observational Study NT-003

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

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

  • Germany
      • Cologne, Germany, 50937
        • Department of Ophthalmology, University of Cologne
      • Freiburg, Germany, 79106
        • University eye hospital Freiburg

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 chronic ocular GvHD

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NovaTears®
Device: NovaTears® Eye Drops
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: 11-13 weeks
Change in subjective symptom severity score compared to Baseline
11-13 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novaliq GmbH

Investigators

  • Study Director: Novaliq GmbH, Novaliq GmbH

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)

January 1, 2016

Study Completion (Actual)

January 1, 2016

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-003

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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