Status:
COMPLETED
Safety and Efficacy of NovaTears® + Omega-3 (0.2%) Eye Drops on Signs and Symptoms of Dry Eye
Lead Sponsor:
Novaliq GmbH
Conditions:
Evaporative Dry Eye Disease
Eligibility:
All Genders
18+ years
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 acc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 9 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 17 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04521465
Start Date
November 9 2020
End Date
February 17 2021
Last Update
April 15 2021
Active Locations (2)
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1
NTO-001 Investigational Site
Heidelberg, Germany, 69121
2
NTO-001 Investigational Site
Nuremberg, Germany, 90403