NovaTears® Eye Drops Observational Study NT-002

Completed

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

• Registration Number: NCT02356341
• Lead Sponsor: Novaliq GmbH

Brief 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.

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: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-08
• Last Update Posted: 2016-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

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

Secondary Outcome Measures

Name	Time	Method
Tear-Film Break-up Time	6 to 8 weeks	Change in Tear Film Break-up Time (measured in seconds) compared to Baseline

Trial Locations

Locations (8)

Prof. Dr. Norbert Schrage; 🇩🇪 Cologne, Germany

University Eye Hospital of the FAU Erlangen-Nuremberg; 🇩🇪 Erlangen, Germany

University Eye Hospital Heidelberg; 🇩🇪 Heidelberg, Germany

Dr. Thomas Kaercher; 🇩🇪 Heidelberg, Germany

University Eye Hospital, LMU Munich; 🇩🇪 Munich, Germany

Staedtisches Klinikum Karlsruhe; 🇩🇪 Karlsruhe, Germany

University Eye Hospital of the HHU Duesseldorf; 🇩🇪 Duesseldorf, Germany

JenVis Research Institute; 🇩🇪 Jena, Germany