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OpenTrials
Completed

NCT Number: NCT03048526

Influence of Perfluorohexyloctane (NovaTears) on Tear Film Thickness in Patients With Mild to Moderate Dry Eye Disease

Patients with mild to moderate dry eye disease will be randomized to receive either NovaTears® or Hydrabak® eye drops as control.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, A-1090, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women aged over 18 years
  • History of dry eye disease for at least 3 months before the screening visit
  • Be able and willing to follow instructions, including participation in all study assessments and visits
  • Signed and dated written informed consent

Exclusion criteria

  • Have any clinically significant slit-lamp findings at the screening visit that may include trauma, Steven Johnson syndrome, and/or in the opinion of the investigator may interfere with study parameters
  • Participation in a clinical trial in the 4 weeks preceding the before the screening visit
  • Active ocular allergies or ocular allergies that are expected to be active during the study period
  • Pregnancy, planned pregnancy or lactating
  • Known hypersensitivity to any component of the study medication
  • Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease

Treatment and study plan

NovaTears®

Device

Topical eye drops for lubrication of the ocular surface

Hydrabak®

Device

Eye drops

Primary outcomes

  1. Tear film thickness as measured with high resolution optical coherence tomography

    Time frame: 4 weeks

Secondary outcomes

  1. Lipid layer thickness

    Time frame: 4 weeks

  2. Non-invasive tear break up time

    Time frame: 4 weeks

  3. Dynamic Meibomian Gland Imaging

    Time frame: 4 weeks

  4. Blink frequency

    Time frame: 4 weeks

  5. Symptom VAS

    Time frame: 4 weeks

  6. Corneal fluorescein staining

    Time frame: 4 weeks

  7. Conjunctival lissamine green staining

    Time frame: 4 weeks

  8. Schirmer I test

    Time frame: 4 weeks

  9. Tear film break up time

    Time frame: 4 weeks

  10. Ocular surface disease index

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Novaliq GmbH

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 9, 2017
Registry last updated
Jul 5, 2017

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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