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Completed

NCT Number: NCT04521465

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

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.

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Key information

Conditions

Evaporative Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NTO-001 Investigational Site, Heidelberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Eye drops

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

    Time frame: 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%).

Sponsors and collaborators

Lead sponsor

Novaliq GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2020
Registry last updated
Apr 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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