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OpenTrials
Completed

NCT Number: NCT02493244

Lipid Layer Thickness Pre and Post Lid Scrubs With Cliradex

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cliradex

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.

Primary outcomes

  1. Lipid layer thickness

    Time frame: Baseline

    Lipid layer thickness measured in nm.

  2. Lipid layer thickness

    Time frame: 1 month after baseline visit.

    Lipid layer thickness measured in nm.

Secondary outcomes

  1. Non-invasive tear breakup time (NITBUT)

    Time frame: Baseline

    Measurement of time taken for a dry spot to appear on the corneal surface after blinking.

  2. Non-invasive tear breakup time (NITBUT)

    Time frame: 1 month after baseline visit.

    Measurement of time taken for a dry spot to appear on the corneal surface after blinking.

  3. Dry Eye Questionnaire (SPEED score)

    Time frame: Baseline

    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.

  4. Dry Eye Questionnaire (SPEED score)

    Time frame: 15 days 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.

  5. Dry Eye Questionnaire (SPEED score)

    Time frame: 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.

  6. Overall corneal staining grade

    Time frame: Baseline

    Overall corneal staining score evaluated on a scale from 0 (none) to 5 (severe). A lower grade indicates less corneal surface desiccation.

  7. Overall corneal staining grade

    Time frame: 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.

  8. Conjunctival hyperemia

    Time frame: Baseline

    Conjunctival hyperemia evaluated on a scale from 0 (negligible) to 100 (severe).

  9. Conjunctival hyperemia

    Time frame: 1 month after baseline visit.

    Conjunctival hyperemia evaluated on a scale from 0 (negligible) to 100 (severe).

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Canadian Optometric Education Trust Fund (COETF)

Registry information

Acronym: HONDA

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 9, 2015
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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