Lipid Layer Thickness Pre and Post Lid Scrubs With Cliradex

NCT ID: NCT02493244

Last Updated: 2016-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-09-30

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.

Conditions

Dry Eye

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Treatment

Participants clean their eyelids with Cliradex wipes before going to bed at night.

Group Type: EXPERIMENTAL

Cliradex

Intervention Type: OTHER

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.

Control

No treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Optometric Education Trust Fund (COETF)

UNKNOWN

Sponsor Role: collaborator

University of Waterloo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lyndon Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

CCLR, University of Waterloo

Locations

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada

Countries

Canada

Other Identifiers

20714

Identifier Type: -

Identifier Source: org_study_id