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Lipid Layer Thickness Pre and Post Lid Scrubs With Cliradex (HONDA)

Primary Purpose

Dry Eye

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cliradex
Sponsored by
University of Waterloo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dry Eye

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Centre for Contact Lens Research, University of Waterloo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

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

No treatment

Outcomes

Primary Outcome Measures

Lipid layer thickness
Lipid layer thickness measured in nm.
Lipid layer thickness
Lipid layer thickness measured in nm.

Secondary Outcome Measures

Non-invasive tear breakup time (NITBUT)
Measurement of time taken for a dry spot to appear on the corneal surface after blinking.
Non-invasive tear breakup time (NITBUT)
Measurement of time taken for a dry spot to appear on the corneal surface after blinking.
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.
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.
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.
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.
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.
Conjunctival hyperemia
Conjunctival hyperemia evaluated on a scale from 0 (negligible) to 100 (severe).
Conjunctival hyperemia
Conjunctival hyperemia evaluated on a scale from 0 (negligible) to 100 (severe).

Full Information

First Posted
June 8, 2015
Last Updated
January 7, 2016
Sponsor
University of Waterloo
Collaborators
Canadian Optometric Education Trust Fund (COETF)
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1. Study Identification

Unique Protocol Identification Number
NCT02493244
Brief Title
Lipid Layer Thickness Pre and Post Lid Scrubs With Cliradex
Acronym
HONDA
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Waterloo
Collaborators
Canadian Optometric Education Trust Fund (COETF)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Participants clean their eyelids with Cliradex wipes before going to bed at night.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No treatment
Intervention Type
Other
Intervention Name(s)
Cliradex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lipid layer thickness
Description
Lipid layer thickness measured in nm.
Time Frame
Baseline
Title
Lipid layer thickness
Description
Lipid layer thickness measured in nm.
Time Frame
1 month after baseline visit.
Secondary Outcome Measure Information:
Title
Non-invasive tear breakup time (NITBUT)
Description
Measurement of time taken for a dry spot to appear on the corneal surface after blinking.
Time Frame
Baseline
Title
Non-invasive tear breakup time (NITBUT)
Description
Measurement of time taken for a dry spot to appear on the corneal surface after blinking.
Time Frame
1 month after baseline visit.
Title
Dry Eye Questionnaire (SPEED score)
Description
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.
Time Frame
Baseline
Title
Dry Eye Questionnaire (SPEED score)
Description
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.
Time Frame
15 days after baseline visit.
Title
Dry Eye Questionnaire (SPEED score)
Description
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.
Time Frame
1 month after baseline visit.
Title
Overall corneal staining grade
Description
Overall corneal staining score evaluated on a scale from 0 (none) to 5 (severe). A lower grade indicates less corneal surface desiccation.
Time Frame
Baseline
Title
Overall corneal staining grade
Description
Overall corneal staining score evaluated on a scale from 0 (none) to 5 (severe). A lower grade indicates less corneal surface desiccation.
Time Frame
1 month after baseline visit.
Title
Conjunctival hyperemia
Description
Conjunctival hyperemia evaluated on a scale from 0 (negligible) to 100 (severe).
Time Frame
Baseline
Title
Conjunctival hyperemia
Description
Conjunctival hyperemia evaluated on a scale from 0 (negligible) to 100 (severe).
Time Frame
1 month after baseline visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD
Organizational Affiliation
CCLR, University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Contact Lens Research, University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

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Lipid Layer Thickness Pre and Post Lid Scrubs With Cliradex

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