NovaTears® Eye Drops 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, University of Cologne, Cologne, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NovaTears® Eye Drops

Device

Topical eye drops for lubrication of the ocular surface

Primary outcomes

Subjective symptom severity

Time frame: 11-13 weeks

Change in subjective symptom severity score compared to Baseline

Secondary outcomes

Tear-Film Break-up Time

Time frame: 11 to 13 weeks

Change in Tear Film Break-up Time (measured in seconds) compared to Baseline

Sponsors and collaborators

Lead sponsor

Novaliq GmbH

Industry

Registry information

Official study title

NovaTears® Observational Study NT-003

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Feb 5, 2015
Registry last updated: Mar 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed