Safety and Efficacy of NovaTears® + Omega-3 (0.2%) Eye Drops on Signs and Symptoms of Dry Eye

Evaporative Dry Eye Disease Clinical Trial

Official title:

A Multi-Center, Single Arm, Post-Market Clinical Follow-up Study to Evaluate the Safety and Efficacy of NovaTears® + Omega-3 (0.2%) Eye Drops on Signs and Symptoms of Dry Eye

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04521465
• Other study ID #: NTO-001
• Status: Completed
• Start date: November 9, 2020
• Est. completion date: February 17, 2021

Study information

• Verified date: April 2021
• Source: Novaliq GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This PMCF study is carried out following successful CE marking of NovaTears® + Omega-3 and is intended to generate systematic clinical data on the safety and performance of the device when used in accordance with the intended purpose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 17, 2021
• Est. primary completion date: February 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed ICF (Informed Consent Form) and data protection form

• Patient-reported history of DED in both eyes

• Have an Ocular Surface Disease Index (OSD) score = 25 at Visit 1

• Have Meibomian Gland Dysfunction (MGD) at Visit 1.

• Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

• Women who are pregnant, nursing or planning a pregnancy

• Ocular surface pathology, clinically significant slit-lamp findings, abnormal lid anatomy, active ocular allergies

• Wear of contact lenses

• Known allergy or sensitivity to the medical device or its components

• Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 60 days before Visit 1.

• Clinical site employees or immediate family members of the same

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Evaporative Dry Eye Disease
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Device:
• NovaTears® + Omega-3 (Perfluorohexyloctane with 0.2% w/w Omega-3 fatty acid ethyl esters)
Eye drops

Locations

Country	Name	City	State
Germany	NTO-001 Investigational Site	Heidelberg
Germany	NTO-001 Investigational Site	Nürnberg

Sponsors (1)

Lead Sponsor	Collaborator
Novaliq GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study is to confirm the performance, relieving symptoms and improving signs of DED, and to evaluate safety and tolerability of topical NovaTears® + Omega-3 (0.2%) eye drops, when used in accordance with its approved labeling	This PMCF study is intended to provide systematic clinical data supporting the safety and performance of the medical device NovaTears® + Omega-3 (0.2%).	2 months