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Completed

NCT Number: NCT02356341

NovaTears® Eye Drops Observational Study NT-002

This observational study is intended to collect outcome data from a cohort of 90 patients suffering from symptoms of dry eye disease due to meibomian gland dysfunction who are treated with the medical device NovaTears® eye drops for a duration of 6 to 8 weeks.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof. Dr. Norbert Schrage, 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 dry eye disease due to meibomian gland dysfunction 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 dry eye disease not caused by meibomian gland dysfunction
  • Patients taking lipid containing eye drops or requiring topical pharmacological 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. Subjective symptom severity

    Time frame: 6 to 8 weeks

    Change in subjective symptom severity score compared to Baseline

Secondary outcomes

  1. Tear-Film Break-up Time

    Time frame: 6 to 8 weeks

    Change in Tear Film Break-up Time (measured in seconds) compared to Baseline

Sponsors and collaborators

Lead sponsor

Novaliq GmbH

Industry

Registry information

Official study title

NovaTears® Observational Study NT-002

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 5, 2015
Registry last updated
Mar 9, 2016

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

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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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