NovaTears® Eye Drops Observational Study

NovaTears® Observational Study

This observational pilot-study is intended to collect outcome data from a cohort of 30 patients suffering from hyper-evaporative dry eye disease who are treated with the medical device NovaTears® eye drops for a duration of 5 to 7 weeks.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Device: NovaTears® Eye Drops

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69121
    • Praxis Dr. Kaercher
  • Koeln, Germany, 50937
    • Zentrum fuer Augenheilkunde Uniklinik Koeln

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with mild to moderate hyper-evaporative dry eye disease

Description

Inclusion Criteria:

• According to NovaTears® instruction for use
• ≥ 18 years
• Patients with mild to moderate disease and hyper-evaporative dry eye disease applying eye lid hygiene for at least 14 days
• Ability and willingness to provide written Informed Consent
• Ability and willingness to participate in all examinations
• Willingness and ability to return for follow up visit

Exclusion Criteria:

• Patients with hypersensitivity to any of the components of NovaTears®
• Patients with contact lenses, pregnancies, or who are breast feeding
• Patients with non evaporate dry eye disease
• Patients taking lipid containing eye drops or requiring pharmacologic treatment of dry eye disease

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NovaTears®	Device: NovaTears® Eye Drops; Topical eye drops for lubrication of the ocular surface

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy measured by routine ophthalmological assessment	Since this is a naturalistic medical device study under EU legislation, the primary outcome is the performance of the device in the intended indication, i.e. the performance claimed by the manufacturer in the instruction for use as determined by routine ophthalmologic assessments. For NovaTears the performance claimed is lubrication of the eye surface, stabilization of the tear film and relieve of symptoms associated with dry eye. These parameters are operationalized by multiple ophthalmological assessment which are part of routine ophthalmologic examinations including tear fluid volume as determined by the Schirmer I test, stability of the tear film as determined by Tear Film Break-Up Time and relieve of symptoms as determined by subjective patient symptom severity questionnaires and objective assessments of the corneal and conjunctival epithelia.	5 to 7 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Local Tolerability measured by ophthalmological assessment	5 to 7 weeks

Collaborators and Investigators

• Sponsor: Novaliq GmbH
• Investigators: Study Director: Michael Beckert, MD, Novaliq GmbH

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: April 7, 2014
• First Submitted That Met QC Criteria: April 9, 2014
• First Posted (Estimate): April 11, 2014

Study Record Updates

• Last Update Posted (Estimate): October 6, 2015
• Last Update Submitted That Met QC Criteria: October 5, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: NT-001