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

Completed

• Conditions: Evaporative Dry Eye Disease
• Interventions: Device: NovaTears® + Omega-3 (Perfluorohexyloctane with 0.2% w/w Omega-3 fatty acid ethyl esters)

• Registration Number: NCT04521465
• Lead Sponsor: Novaliq GmbH

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-20
• Study Start: 2020-11-09
• Primary Completion: 2021-02-17
• Study Completion: 2021-02-17
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NovaTears® + Omega-3	NovaTears® + Omega-3 (Perfluorohexyloctane with 0.2% w/w Omega-3 fatty acid ethyl esters)	-

Primary Outcome Measures

Name	Time	Method
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	2 months	This PMCF study is intended to provide systematic clinical data supporting the safety and performance of the medical device NovaTears® + Omega-3 (0.2%).

Trial Locations

Locations (1)

NTO-001 Investigational Site; 🇩🇪 Nürnberg, Germany