Dry Eye Disease Clinical Trial
Official title:
Influence of Perfluorohexyloctane (NovaTears) on Tear Film Thickness in Patients With Mild to Moderate Dry Eye Disease
Verified date | July 2017 |
Source | Novaliq GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with mild to moderate dry eye disease will be randomized to receive either NovaTears® or Hydrabak® eye drops as control.
Status | Completed |
Enrollment | 48 |
Est. completion date | April 18, 2017 |
Est. primary completion date | April 18, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna, Department of Clinical Pharmacology | Vienna |
Lead Sponsor | Collaborator |
---|---|
Novaliq GmbH |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tear film thickness as measured with high resolution optical coherence tomography | 4 weeks | ||
Secondary | Lipid layer thickness | 4 weeks | ||
Secondary | Non-invasive tear break up time | 4 weeks | ||
Secondary | Dynamic Meibomian Gland Imaging | 4 weeks | ||
Secondary | Blink frequency | 4 weeks | ||
Secondary | Symptom VAS | 4 weeks | ||
Secondary | Corneal fluorescein staining | 4 weeks | ||
Secondary | Conjunctival lissamine green staining | 4 weeks | ||
Secondary | Schirmer I test | 4 weeks | ||
Secondary | Tear film break up time | 4 weeks | ||
Secondary | Ocular surface disease index | 4 weeks |
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