Lipid Layer Thickness Pre and Post Lid Scrubs With Cliradex

Study Overview
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Brief Summary
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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.

Conditions
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Dry Eye

Intervention / Treatment
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* Other: Cliradex


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Participants clean their eyelids with Cliradex wipes before going to bed at night. | Other: Cliradex<br>* 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.<br>|
| No Intervention: Control<br>No treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid layer thickness | Lipid layer thickness measured in nm. | Baseline | 
| Lipid layer thickness | Lipid layer thickness measured in nm. | 1 month after baseline visit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-invasive tear breakup time (NITBUT) | Measurement of time taken for a dry spot to appear on the corneal surface after blinking. | Baseline | 
| Non-invasive tear breakup time (NITBUT) | Measurement of time taken for a dry spot to appear on the corneal surface after blinking. | 1 month after baseline visit. | 
| Dry Eye Questionnaire (SPEED score) | 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. | Baseline | 
| Dry Eye Questionnaire (SPEED score) | 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. | 15 days after baseline visit. | 
| Dry Eye Questionnaire (SPEED score) | 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. | 1 month after baseline visit. | 
| Overall corneal staining grade | Overall corneal staining score evaluated on a scale from 0 (none) to 5 (severe). A lower grade indicates less corneal surface desiccation. | Baseline | 
| Overall corneal staining grade | Overall corneal staining score evaluated on a scale from 0 (none) to 5 (severe). A lower grade indicates less corneal surface desiccation. | 1 month after baseline visit. | 
| Conjunctival hyperemia | Conjunctival hyperemia evaluated on a scale from 0 (negligible) to 100 (severe). | Baseline | 
| Conjunctival hyperemia | Conjunctival hyperemia evaluated on a scale from 0 (negligible) to 100 (severe). | 1 month after baseline visit. |