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

NCT04521465 | Completed

• 1 other identifier: NTO-001
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Evaporative Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

NovaTears® + Omega-3

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

Interventions

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

Eye drops

NovaTears® + Omega-3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with evaporative Dry Eye Disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novaliq GmbH: lead

Study Sites (2)

NTO-001 Investigational Site

Heidelberg, 69121, Germany

Location

NTO-001 Investigational Site

Nuremberg, 90403, Germany

Location

Related Publications (1)

• Jacobi C, Angstmann-Mehr S, Lange A, Kaercher T. A Water-Free Omega-3 Fatty Acid Eye Drop Formulation for the Treatment of Evaporative Dry Eye Disease: A Prospective, Multicenter Noninterventional Study. J Ocul Pharmacol Ther. 2022 Jun;38(5):348-353. doi: 10.1089/jop.2021.0102. Epub 2022 May 4.

  PMID: 35507946 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Sonja Kroesser, PhD

  Novaliq GmbH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 20, 2020
• Study Start: November 9, 2020
• Primary Completion: February 17, 2021
• Study Completion: February 17, 2021
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)