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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

Tracking Information
First Submitted Date  ICMJE February 7, 2017
First Posted Date  ICMJE February 9, 2017
Last Update Posted Date July 5, 2017
Actual Study Start Date  ICMJE December 15, 2016
Actual Primary Completion Date April 18, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
Tear film thickness as measured with high resolution optical coherence tomography [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
  • Lipid layer thickness [ Time Frame: 4 weeks ]
  • Non-invasive tear break up time [ Time Frame: 4 weeks ]
  • Dynamic Meibomian Gland Imaging [ Time Frame: 4 weeks ]
  • Blink frequency [ Time Frame: 4 weeks ]
  • Symptom VAS [ Time Frame: 4 weeks ]
  • Corneal fluorescein staining [ Time Frame: 4 weeks ]
  • Conjunctival lissamine green staining [ Time Frame: 4 weeks ]
  • Schirmer I test [ Time Frame: 4 weeks ]
  • Tear film break up time [ Time Frame: 4 weeks ]
  • Ocular surface disease index [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Perfluorohexyloctane (NovaTears) on Tear Film Thickness in Patients With Mild to Moderate Dry Eye Disease
Official Title  ICMJE Influence of Perfluorohexyloctane (NovaTears) on Tear Film Thickness in Patients With Mild to Moderate Dry Eye Disease
Brief Summary Patients with mild to moderate dry eye disease will be randomized to receive either NovaTears® or Hydrabak® eye drops as control.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Disease
Intervention  ICMJE
  • Device: NovaTears®
    Topical eye drops for lubrication of the ocular surface
  • Device: Hydrabak®
    Eye drops
Study Arms  ICMJE
  • Experimental: NovaTears®
    Intervention: Device: NovaTears®
  • Active Comparator: Hydrabak®
    Unpreserved sodium chloride (0.9%) eye drops in ABAK® system
    Intervention: Device: Hydrabak®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2017)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 18, 2017
Actual Primary Completion Date April 18, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03048526
Other Study ID Numbers  ICMJE NT-004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novaliq GmbH
Study Sponsor  ICMJE Novaliq GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gerhard Garhoefer, MD Novaliq GmbH
PRS Account Novaliq GmbH
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP