NovaTears® Eye Drops Observational Study NT-002

March 8, 2016 updated by: Novaliq GmbH

NovaTears® Observational Study NT-002

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

72

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, 50765
        • Prof. Dr. Norbert Schrage
      • Duesseldorf, Germany, 40225
        • University Eye Hospital of the HHU Duesseldorf
      • Erlangen, Germany, 91054
        • University Eye Hospital of the FAU Erlangen-Nuremberg
      • Heidelberg, Germany, 69120
        • University Eye Hospital Heidelberg
      • Heidelberg, Germany, 69121
        • Dr. Thomas Kaercher
      • Jena, Germany, 07745
        • JenVis Research Institute
      • Karlsruhe, Germany, 76133
        • Staedtisches Klinikum Karlsruhe
      • Munich, Germany, 80336
        • University Eye Hospital, LMU Munich

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 meibomian gland dysfunction

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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: 6 to 8 weeks
Change in subjective symptom severity score compared to Baseline
6 to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tear-Film Break-up Time
Time Frame: 6 to 8 weeks
Change in Tear Film Break-up Time (measured in seconds) compared to Baseline
6 to 8 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2015

Study Completion (Actual)

December 1, 2015

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-002

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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