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

Novaliq

Status: Completed

Conditions: Evaporative Dry Eye Disease

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

Study type: Observational

Funder types: Industry

Identifiers

NCT04521465

NTO-001

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

36 participants in 1 patient group

NovaTears® + Omega-3

Treatment:

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