NovaTears® Eye Drops Observational Study

Completed

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

• Registration Number: NCT02111928
• Lead Sponsor: Novaliq GmbH

Brief Summary

This observational pilot-study is intended to collect outcome data from a cohort of 30 patients suffering from hyper-evaporative dry eye disease who are treated with the medical device NovaTears® eye drops for a duration of 5 to 7 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-09
• Study First Posted: 2014-04-11
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• According to NovaTears® instruction for use
• ≥ 18 years
• Patients with mild to moderate disease and hyper-evaporative dry eye disease 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 non evaporate dry eye disease
• Patients taking lipid containing eye drops or requiring pharmacologic 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
Efficacy measured by routine ophthalmological assessment	5 to 7 weeks	Since this is a naturalistic medical device study under EU legislation, the primary outcome is the performance of the device in the intended indication, i.e. the performance claimed by the manufacturer in the instruction for use as determined by routine ophthalmologic assessments. For NovaTears the performance claimed is lubrication of the eye surface, stabilization of the tear film and relieve of symptoms associated with dry eye. These parameters are operationalized by multiple ophthalmological assessment which are part of routine ophthalmologic examinations including tear fluid volume as determined by the Schirmer I test, stability of the tear film as determined by Tear Film Break-Up Time and relieve of symptoms as determined by subjective patient symptom severity questionnaires and objective assessments of the corneal and conjunctival epithelia.

Secondary Outcome Measures

Name	Time	Method
Local Tolerability measured by ophthalmological assessment	5 to 7 weeks

Trial Locations

Locations (2)

Praxis Dr. Kaercher; 🇩🇪 Heidelberg, Germany

Zentrum fuer Augenheilkunde Uniklinik Koeln; 🇩🇪 Koeln, Germany