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Trial record 48 of 8404 for:    Ophthalmopathy

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03048526
Recruitment Status : Completed
First Posted : February 9, 2017
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Novaliq GmbH

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

Condition or disease Intervention/treatment Phase
Dry Eye Disease Device: NovaTears® Device: Hydrabak® Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Influence of Perfluorohexyloctane (NovaTears) on Tear Film Thickness in Patients With Mild to Moderate Dry Eye Disease
Actual Study Start Date : December 15, 2016
Actual Primary Completion Date : April 18, 2017
Actual Study Completion Date : April 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases Tears

Arm Intervention/treatment
Experimental: NovaTears® Device: NovaTears®
Topical eye drops for lubrication of the ocular surface

Active Comparator: Hydrabak®
Unpreserved sodium chloride (0.9%) eye drops in ABAK® system
Device: Hydrabak®
Eye drops




Primary Outcome Measures :
  1. Tear film thickness as measured with high resolution optical coherence tomography [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048526


Locations
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Austria
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, Austria, A-1090
Sponsors and Collaborators
Novaliq GmbH
Investigators
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Study Director: Gerhard Garhoefer, MD Novaliq GmbH

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Responsible Party: Novaliq GmbH
ClinicalTrials.gov Identifier: NCT03048526     History of Changes
Other Study ID Numbers: NT-004
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases