- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02493244
Lipid Layer Thickness Pre and Post Lid Scrubs With Cliradex (HONDA)
January 7, 2016 updated by: University of Waterloo
Tears play a vital role in vision.
A thin layer of tears is always present to cover the surface of the eye for optimal comfort and vision.
There are several layers to the tear film, and the outer most layer is comprised of lipids.
This lipid layer prevents evaporation of the tears and may be disrupted in people suffering from symptoms of dry eye.
Cleaning eyelids with Cliradex wipes have shown to be effective in reducing dry eye symptoms in some patients, and the purpose of this study is to evaluate the tear film lipid layer thickness before and after one months treatment with Cliradex Wipes.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Waterloo, Ontario, Canada, N2L 3G1
- Centre for Contact Lens Research, University of Waterloo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Have not worn contact lenses in the past month;
- Has symptomatic dry eye with SPEED questionnaire score ≥6;
- Corneal staining grade ≥2 on the Oxford scale.
Exclusion Criteria:
- Has any known active ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Have used rewetting drops for a period of 2 days prior to screening visit;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment by verbal confirmation at the screening visit;
- Is aphakic;
- Has undergone refractive error surgery;
- Has taken part in another (pharmaceutical) research study within the last 30 days.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
No treatment
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Experimental: Treatment
Participants clean their eyelids with Cliradex wipes before going to bed at night.
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Cliradex is simply water and 4-Terpineol, a natural organic compound found Melaleuca alternifolia.
The other ingredients in Cliradex are in less than 1% of the formulation and are Glycerin, Polysorbate 20, Polysorbate 80, Carbomer, Triethanolamine.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lipid layer thickness
Time Frame: Baseline
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Lipid layer thickness measured in nm.
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Baseline
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Lipid layer thickness
Time Frame: 1 month after baseline visit.
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Lipid layer thickness measured in nm.
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1 month after baseline visit.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Non-invasive tear breakup time (NITBUT)
Time Frame: Baseline
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Measurement of time taken for a dry spot to appear on the corneal surface after blinking.
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Baseline
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Non-invasive tear breakup time (NITBUT)
Time Frame: 1 month after baseline visit.
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Measurement of time taken for a dry spot to appear on the corneal surface after blinking.
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1 month after baseline visit.
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Dry Eye Questionnaire (SPEED score)
Time Frame: Baseline
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Standard Patient Evaluation of Eye Dryness questionnaire.
Assessment of subjects' frequency and severity of dry eye symptoms.
The total score was calculated as the sum scores for all symptoms over a range of 0 to 28.
A lower total SPEED score represents less frequent and/or less severe symptoms.
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Baseline
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Dry Eye Questionnaire (SPEED score)
Time Frame: 15 days after baseline visit.
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Standard Patient Evaluation of Eye Dryness questionnaire.
Assessment of subjects' frequency and severity of dry eye symptoms.
The total score was calculated as the sum scores for all symptoms over a range of 0 to 28.
A lower total SPEED score represents less frequent and/or less severe symptoms.
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15 days after baseline visit.
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Dry Eye Questionnaire (SPEED score)
Time Frame: 1 month after baseline visit.
|
Standard Patient Evaluation of Eye Dryness questionnaire.
Assessment of subjects' frequency and severity of dry eye symptoms.
The total score was calculated as the sum scores for all symptoms over a range of 0 to 28.
A lower total SPEED score represents less frequent and/or less severe symptoms.
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1 month after baseline visit.
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Overall corneal staining grade
Time Frame: Baseline
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Overall corneal staining score evaluated on a scale from 0 (none) to 5 (severe).
A lower grade indicates less corneal surface desiccation.
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Baseline
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Overall corneal staining grade
Time Frame: 1 month after baseline visit.
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Overall corneal staining score evaluated on a scale from 0 (none) to 5 (severe).
A lower grade indicates less corneal surface desiccation.
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1 month after baseline visit.
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Conjunctival hyperemia
Time Frame: Baseline
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Conjunctival hyperemia evaluated on a scale from 0 (negligible) to 100 (severe).
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Baseline
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Conjunctival hyperemia
Time Frame: 1 month after baseline visit.
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Conjunctival hyperemia evaluated on a scale from 0 (negligible) to 100 (severe).
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1 month after baseline visit.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lyndon Jones, PhD, CCLR, University of Waterloo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
June 8, 2015
First Submitted That Met QC Criteria
July 6, 2015
First Posted (Estimate)
July 9, 2015
Study Record Updates
Last Update Posted (Estimate)
January 8, 2016
Last Update Submitted That Met QC Criteria
January 7, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20714
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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