NovaTears® Eye Drops Observational Study NT-002

Dry Eye Syndromes Clinical Trial

Official title:

NovaTears® Observational Study NT-002

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356341
• Other study ID #: NT-002
• Status: Completed
• Phase: N/A
• First received: January 21, 2015
• Last updated: March 8, 2016
• Start date: January 2015
• Est. completion date: December 2015

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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	Prof. Dr. Norbert Schrage	Cologne
Germany	University Eye Hospital of the HHU Duesseldorf	Duesseldorf
Germany	University Eye Hospital of the FAU Erlangen-Nuremberg	Erlangen
Germany	Dr. Thomas Kaercher	Heidelberg
Germany	University Eye Hospital Heidelberg	Heidelberg
Germany	JenVis Research Institute	Jena
Germany	Staedtisches Klinikum Karlsruhe	Karlsruhe
Germany	University Eye Hospital, LMU Munich	Munich

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	6 to 8 weeks	No
Secondary	Tear-Film Break-up Time	Change in Tear Film Break-up Time (measured in seconds) compared to Baseline	6 to 8 weeks	No