NovaTears® Eye Drops Observational Study NT-003

Dry Eye Syndromes Clinical Trial

Official title:

NovaTears® Observational Study NT-003

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356328
• Other study ID #: NT-003
• Status: Completed
• Phase: N/A
• First received: January 21, 2015
• Last updated: March 8, 2016
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Novaliq GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• NovaTears® Eye Drops
Topical eye drops for lubrication of the ocular surface

Locations

Country	Name	City	State
Germany	Department of Ophthalmology, University of Cologne	Cologne
Germany	University Eye Hospital Freiburg	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
Novaliq GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective symptom severity	Change in subjective symptom severity score compared to Baseline	11-13 weeks	No
Secondary	Tear-Film Break-up Time	Change in Tear Film Break-up Time (measured in seconds) compared to Baseline	11 to 13 weeks	No