Lipid Layer Thickness Pre and Post Lid Scrubs With Cliradex

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Other: Cliradex

• Registration Number: NCT02493244
• Lead Sponsor: University of Waterloo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-08
• Study First Submitted QC: 2015-07-06
• Study First Posted: 2015-07-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-07
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Cliradex	Participants clean their eyelids with Cliradex wipes before going to bed at night.

Primary Outcome Measures

Name	Time	Method
Lipid layer thickness	1 month after baseline visit.	Lipid layer thickness measured in nm.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre for Contact Lens Research, University of Waterloo; 🇨🇦 Waterloo, Ontario, Canada