Clinical trial NCT02493244: Lipid Layer Thickness Pre and Post Lid Scrubs With Cliradex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Canadian Optometric Education Trust Fund (COETF)
First posted: 2015-07-09
Enrollment: 20
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Lipid layer thickness
timeFrame: Baseline
measure: Lipid layer thickness
timeFrame: 1 month after baseline visit.
Secondary outcomes:
measure: Non-invasive tear breakup time (NITBUT)
timeFrame: Baseline
measure: Non-invasive tear breakup time (NITBUT)
timeFrame: 1 month after baseline visit.
measure: Dry Eye Questionnaire (SPEED score)
timeFrame: Baseline
measure: Dry Eye Questionnaire (SPEED score)
timeFrame: 15 days after baseline visit.
measure: Dry Eye Questionnaire (SPEED score)
timeFrame: 1 month after baseline visit.
measure: Overall corneal staining grade
timeFrame: Baseline
measure: Overall corneal staining grade
timeFrame: 1 month after baseline visit.
measure: Conjunctival hyperemia
timeFrame: Baseline
measure: Conjunctival hyperemia
timeFrame: 1 month after baseline visit.
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research, University of Waterloo
state: Ontario
Study officials:
affiliation: CCLR, University of Waterloo
name: Lyndon Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: