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Completed

NCT Number: NCT02111928

NovaTears® Eye Drops 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.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zentrum fuer Augenheilkunde Uniklinik Koeln, Cologne, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NovaTears® Eye Drops

Device

Topical eye drops for lubrication of the ocular surface

Primary outcomes

  1. Efficacy measured by routine ophthalmological assessment

    Time frame: 5 to 7 weeks

    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.

Secondary outcomes

  1. Local Tolerability measured by ophthalmological assessment

    Time frame: 5 to 7 weeks

Sponsors and collaborators

Lead sponsor

Novaliq GmbH

Industry

Registry information

Official study title

NovaTears® Observational Study

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 11, 2014
Registry last updated
Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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