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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-09

Study Completion Date

2021-02-17

Brief Summary

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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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Detailed Description

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Conditions

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Evaporative Dry Eye Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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NovaTears® + Omega-3

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

Intervention Type DEVICE

Eye drops

Interventions

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

Eye drops

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No