Dry EyeHONDANCT02493244
Lipid Layer Thickness Pre and Post Lid Scrubs With Cliradex
A study testing Cliradex in people with Dry Eye, run by University of Waterloo at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Cliradex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Is aphakic;
- Has undergone refractive error surgery;
- Has taken part in another (pharmaceutical) research study within the last 30 days.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, N2L 3G1
About this study
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
- Being tested
- Cliradex
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CliradexOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants clean their eyelids with Cliradex wipes before going to bed at night. Receives: Other: Cliradex |
| Control | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid layer thickness
Lipid layer thickness measured in nm.
Measured: Baseline
Lipid layer thickness
Lipid layer thickness measured in nm.
Measured: 1 month after baseline visit.
Secondary outcomes (9)
Non-invasive tear breakup time (NITBUT)
Measurement of time taken for a dry spot to appear on the corneal surface after blinking.
Measured: Baseline
Non-invasive tear breakup time (NITBUT)
Measurement of time taken for a dry spot to appear on the corneal surface after blinking.
Measured: 1 month after baseline visit.
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.
Measured: Baseline
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.
Measured: 15 days after baseline visit.
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.
Measured: 1 month after baseline visit.
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.
Measured: Baseline
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.
Measured: 1 month after baseline visit.
Conjunctival hyperemia
Conjunctival hyperemia evaluated on a scale from 0 (negligible) to 100 (severe).
Measured: Baseline
Conjunctival hyperemia
Conjunctival hyperemia evaluated on a scale from 0 (negligible) to 100 (severe).
Measured: 1 month after baseline visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Optometric Education Trust Fund (COETF)
- Responsible party
- Sponsor
- Investigators
- Lyndon Jones, PhD, Principal investigator, CCLR, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493244
- Sponsor's protocol ID
- 20714
- Acronym
- HONDA
- Status last verified
- Jan 2016
- First submitted
- 8 Jun 2015
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid Layer Thickness Pre and Post Lid Scrubs With Cliradex
- ClinicalTrials.gov ID
- NCT02493244
- Acronym / sponsor ID
- HONDA / 20714
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Canadian Optometric Education Trust Fund (COETF)
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: CliradexParticipants clean their eyelids with Cliradex wipes before going to bed at night. |
| Control | No intervention | –No treatment |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CliradexCliradex 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. | Other | Treatment |
Primary outcome
Lipid layer thickness
Time frame: Baseline
Lipid layer thickness measured in nm.
Lipid layer thickness
Time frame: 1 month after baseline visit.
Lipid layer thickness measured in nm.
9 secondary outcomes
Non-invasive tear breakup time (NITBUT)
Time frame: Baseline
Non-invasive tear breakup time (NITBUT)
Time frame: 1 month after baseline visit.
Dry Eye Questionnaire (SPEED score)
Time frame: Baseline
Dry Eye Questionnaire (SPEED score)
Time frame: 15 days after baseline visit.
Dry Eye Questionnaire (SPEED score)
Time frame: 1 month after baseline visit.
Overall corneal staining grade
Time frame: Baseline
Overall corneal staining grade
Time frame: 1 month after baseline visit.
Conjunctival hyperemia
Time frame: Baseline
Conjunctival hyperemia
Time frame: 1 month after baseline visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyndon Jones, PhD principal investigator
CCLR, University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cliradex in people with Dry Eye, run by University of Waterloo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid layer thickness (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.