NovaTears® Eye Drops Observational Study NT-003

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Device: NovaTears® Eye Drops

• Registration Number: NCT02356328
• Lead Sponsor: Novaliq GmbH

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 available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-02-01
• Study First Posted: 2015-02-05
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-08
• Last Update Posted: 2016-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NovaTears®	NovaTears® Eye Drops	-

Primary Outcome Measures

Name	Time	Method
Subjective symptom severity	11-13 weeks	Change in subjective symptom severity score compared to Baseline

Secondary Outcome Measures

Name	Time	Method
Tear-Film Break-up Time	11 to 13 weeks	Change in Tear Film Break-up Time (measured in seconds) compared to Baseline

Trial Locations

Locations (2)

University Eye Hospital Freiburg; 🇩🇪 Freiburg, Germany

Department of Ophthalmology, University of Cologne; 🇩🇪 Cologne, Germany