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

• Sponsor: Novaliq GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04521465
• Collaborator: (none)
• Enrollment: 36
• Locations: 2
• Actual Duration (Months): 3.3
• Patients Per Site: 18
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Evaporative Dry Eye Disease	Device: NovaTears® + Omega-3 (Perfluorohexyloctane with 0.2% w/w Omega-3 fatty acid ethyl esters)

Study Design

• Study Type: Observational
• Actual Enrollment: 36 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official 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
• Actual Study Start Date: Nov 9, 2020
• Actual Primary Completion Date: Feb 17, 2021
• Actual Study Completion Date: Feb 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
NovaTears® + Omega-3	Device: NovaTears® + Omega-3 (Perfluorohexyloctane with 0.2% w/w Omega-3 fatty acid ethyl esters); Eye drops

Outcome Measures

Primary Outcome Measures

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 [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%).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NTO-001 Investigational Site	Heidelberg		Germany	69121
2	NTO-001 Investigational Site	Nürnberg		Germany	90403

Sponsors and Collaborators

• Novaliq GmbH

Investigators

• Study Director: Sonja Kroesser, PhD, Novaliq GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novaliq GmbH
• ClinicalTrials.gov Identifier: NCT04521465
• Other Study ID Numbers: NTO-001
• First Posted: Aug 20, 2020
• Last Update Posted: Apr 15, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases

Study Results

No Results Posted as of Apr 15, 2021