Lipid Layer Thickness Pre and Post Lid Scrubs With Cliradex

Dry Eye Clinical Trial

— HONDA  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02493244
• Other study ID #: 20714
• Status: Completed
• Phase: N/A
• First received: June 8, 2015
• Last updated: January 7, 2016
• Start date: June 2015
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Clinical Research Ethics CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

1. Is at least 17 years of age and has full legal capacity to volunteer;

2. Has read and signed an information consent letter;

3. Is willing and able to follow instructions and maintain the appointment schedule;

4. Have not worn contact lenses in the past month;

5. Has symptomatic dry eye with SPEED questionnaire score =6;

6. Corneal staining grade =2 on the Oxford scale.

Exclusion Criteria:

1. Has any known active ocular disease and/or infection;

2. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

3. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

4. Have used rewetting drops for a period of 2 days prior to screening visit;

5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

6. Is pregnant, lactating or planning a pregnancy at the time of enrolment by verbal confirmation at the screening visit;

7. Is aphakic;

8. Has undergone refractive error surgery;

9. Has taken part in another (pharmaceutical) research study within the last 30 days.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dry Eye

Intervention

Other:
• Cliradex
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.

Locations

Country	Name	City	State
Canada	Centre for Contact Lens Research, University of Waterloo	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	Canadian Optometric Education Trust Fund (COETF)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipid layer thickness	Lipid layer thickness measured in nm.	Baseline	No
Primary	Lipid layer thickness	Lipid layer thickness measured in nm.	1 month after baseline visit.	No
Secondary	Non-invasive tear breakup time (NITBUT)	Measurement of time taken for a dry spot to appear on the corneal surface after blinking.	Baseline	No
Secondary	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.	No
Secondary	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	No
Secondary	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.	No
Secondary	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.	No
Secondary	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	No
Secondary	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.	No
Secondary	Conjunctival hyperemia	Conjunctival hyperemia evaluated on a scale from 0 (negligible) to 100 (severe).	Baseline	No
Secondary	Conjunctival hyperemia	Conjunctival hyperemia evaluated on a scale from 0 (negligible) to 100 (severe).	1 month after baseline visit.	No