BlepharitisNCT03422146
Antimicrobial and Clinical Efficacy of Cliradex® as Compared With I-Lid'n Lash® Hygiene in Treating Blepharitis
A study testing Tea Tree Oil (TTO) and I-Lid'n Lash® Hygiene in people with Blepharitis and Meibomian Gland Dysfunction, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Previous studies have shown the clinical and antimicrobial efficacy of eyelid hygiene with tea tree oil (TTO) in resolving chronic blepharitis. Cliradex® is a novel over-the-counter eyelid wipe which contains the most active ingredient of TTO. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blepharitis, Meibomian Gland Dysfunction
- What is being tested?
- Tea Tree Oil (TTO) and I-Lid'n Lash® Hygiene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 19 Feb 2017to Jan 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with symptomatic blepharitis for duration of at least 3 months.
- Male and female age range: > 18 years old.
- All ethnic groups comparable with the local community.
- Patients able and willing to cooperate with the investigational plan.
- Patients able and willing to complete all postoperative follow-up visits.
- Able to understand and willing to sign a written informed consent.
Who cannot join
- Patients who are currently engaged in another clinical trial.
- Patients who are unwilling or unable to give consent.
- Patients who are unwilling to accept randomization.
- Patients who will not be able to return for scheduled visits.
- Children under 18.
- Concomitant use of ophthalmic topical medications (excluding non-preserved tear substitutes).
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- Concomitant use of systemic antibiotics or steroids.
- Active ocular infection or allergy.
- Previous surgery on the eyelids such as blepharoplasty.
- Abraded skin on or around the eyelids.
- Patients unable to close eyes or uncontrolled blinking.
- Previous allergic reaction to TTO-containing products or cosmetic fragrance.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Ottawa Health Research Institute
Ottawa, Ontario, K1H 8L6
Annelise M Saunders, CCRP, 613-737-8657, ansaunders@toh.ca
Setareh Ziai, MD
About this study
Official title: Antimicrobial and Clinical Efficacy of Cliradex® as Compared With I-Lid'n Lash® Hygiene in Treating Blepharitis: A Randomized, Outcomes-Assessor Masked, Clinical Trial
Previous studies have shown the clinical and antimicrobial efficacy of eyelid hygiene with tea tree oil (TTO) in resolving chronic blepharitis. Cliradex® is a novel over-the-counter eyelid wipe which contains the most active ingredient of TTO. The present study is a single-centre, randomized, trial comparing Cliradex® eyelid hygiene and I-Lid 'n Lash® Hygiene, another over-the-counter eyelid wipe, without any medicinal ingredients, in treating chronic blepharitis. The Primary Outcome Measure will be the difference in change in the number of CFU's after 2 weeks treatment, between the groups. The Secondary Outcome Measure will be the difference in change in objective clinical signs and symptoms by performing a vision check, a questionnaire, and visual grading, of each participants' blepharitis after 2 weeks treatment, between the groups. The Tertiary Outcome Measures will be the difference in change in microbial CFUs and clinical signs and symptoms between the groups at the 4 and 6 week point, (2 and 4 weeks after discontinuing treatment), to evaluate if the treatment will produce a lasting effect.
Participants will be randomized into one of the treatment arms. They will use the appropriate treatment for two weeks. They will then be re-assessed. They will discontinue treatment at this time, and four weeks later, will be assessed one last time, to see if the temporary treatment provides a lasting effect. A sub-group of ten patients per group will also be randomized to an extra visit. This group will be assessed after two weeks of having stopped the wipes. The same testing and procedures will be performed at this appointment.
Read the detailed description
Previous studies have shown the clinical and antimicrobial efficacy of eyelid hygiene with tea tree oil (TTO) in resolving chronic blepharitis. This randomized, outcomes-assessor masked, clinical trial aims to determine the efficacy of Cliradex®, which contains the most active ingredient of (TTO), as compared with I-Lid 'n Lash® Hygiene, in treating chronic blepharitis
Blepharitis is a family of inflammatory disease processes of the eyelid. It can be divided anatomically into anterior and posterior blepharitis. Anterior blepharitis refers to inflammation mainly centered around the eyelashes and follicles, while the posterior variant involves the meibomian gland orifices. Anterior blepharitis usually is subdivided further into staphylococcal and seborrheic variants. Frequently, a considerable overlap exists in these processes in individual patients. Blepharitis often is associated with systemic diseases, such as rosacea and seborrheic dermatitis, as well as ocular diseases, such as dry eye syndromes, chalazion, trichiasis, conjunctivitis, and keratitis.1-3
The pathophysiology of blepharitis involves bacterial colonization of the eyelids. This results in direct microbial invasion of tissues, immune system-mediated damage, or damage caused by the production of bacterial toxins, waste products, and enzymes. Colonization of the lid margin is in-creased in the presence of seborrheic dermatitis or meibomian gland dysfunction.1-3
Blepharitis can be difficult to manage because it is often chronic or tends to recur. Despite the cause, eyelid hygiene is the cornerstone of treatment for most cases of blepharitis. This includes the use of commercially available over-the-counter lid cleansing wipes. Previous studies have shown the clinical and microbial efficacy of lid scrubs with tea tree oil (TTO) in resolving chronic blepharitis; however, lid scrubs based on TTO are not convenient for self-administration and cause irritation in some patients.4-11
Cliradex® (Bio-Tissue, Miami, FL) is a commercially available cosmetic pad containing the most active ingredient of TTO, which also exerts potent anti-microbial effects which may eliminate the need for systemic and/or topical antibiotic therapy for blepharitis.
In this trial, the investigators propose to conduct a randomized, outcomes assessor masked, clinical trial to determine the clinical and antimicrobial efficacy of Cliradex® and I-Lid 'n Lash® Hygiene, in improving the signs and symptoms of blepharitis, as well as decreasing the microbial flora in these patients.
- Conditions
- Blepharitis, Meibomian Gland Dysfunction
- Being tested
- Tea Tree Oil (TTO), I-Lid'n Lash® Hygiene
- Medical subject headings
- Blepharitis, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tea Tree Oil (TTO)Other
Participants will use the Cliradex® eyelid hygiene lid wipe / towelette for BID for 2 weeks
I-Lid'n Lash® HygieneOther
Patients will use the I-Lid'n Lash® Hygiene lid wipe / towelette for BID for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cliradex® eyelid hygiene | Experimental | Cliradex® is a novel over-the-counter eyelid wipe which contains the most active ingredient of TTO. Previous studies have shown the clinical and antimicrobial efficacy of eyelid hygiene with tea tree oil (TTO) in resolving chronic blepharitis. Receives: Other: Tea Tree Oil (TTO) |
| I-Lid 'n Lash® Hygiene | Other | Lid 'n Lash® Hygiene, is an over-the-counter eyelid wipe, without any medicinal ingredients, Receives: Other: I-Lid'n Lash® Hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of microbiologic improvement
difference in change in the number of CFU's after 2 weeks treatment, between the groups. (Note: colony counts over 200 will not be counted but reported as >200)
Measured: 2 weeks
Secondary outcomes (2)
Improvement in signs & symptoms of blepharitis based on visual grading scale
The Secondary Outcome Measure will be the difference in change in objective clinical signs and symptoms using a visual grading scale
Measured: 2 weeks
Improvement in signs & symptoms of blepharitis based on participant questionnaire
The Secondary Outcome Measure will be the difference in change in objective clinical signs and symptoms using a questionnaire after 2 weeks treatment between the groups.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start19 Feb 2017
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharitisStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a single-centre, randomized, outcomes-assessor masked trial with two groups. Patients with chronic blepharitis will be randomized into either the Cliradex® eyelid hygiene or I-Lid 'n Lash® Hygiene group. There will be 20 participants enrolled in each group. Although both eyes will receive treatment, only the worse eye will be enrolled in the study. In addition to randomizing the participants into treatment group they will also be placed by chance into either the 3 visit or 4 visit group (n=10 per group).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Setareh Ziai, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422146
- Sponsor's protocol ID
- P20130792-01H
- Status last verified
- Jan 2018
- First submitted
- 12 Dec 2017
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial and Clinical Efficacy of Cliradex® as Compared With I-Lid'n Lash® Hygiene in Treating Blepharitis: A Randomized, Outcomes-Assessor Masked, Clinical Trial
- ClinicalTrials.gov ID
- NCT03422146
- Acronym / sponsor ID
- P20130792-01H
- Conditions
- Blepharitis, Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 19 Feb 2017 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 5 Feb 2018 (actual)
- 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.
Previous studies have shown the clinical and antimicrobial efficacy of eyelid hygiene with tea tree oil (TTO) in resolving chronic blepharitis. Cliradex® is a novel over-the-counter eyelid wipe which contains the most active ingredient of TTO. The present study is a single-centre, randomized, trial comparing Cliradex® eyelid hygiene and I-Lid 'n Lash® Hygiene, another over-the-counter eyelid wipe, without any medicinal ingredients, in treating chronic blepharitis. The Primary Outcome Measure will be the difference in change in the number of CFU's after 2 weeks treatment, between the groups. The Secondary Outcome Measure will be the difference in change in objective clinical signs and symptoms by performing a vision check, a questionnaire, and visual grading, of each participants' blepharitis after 2 weeks treatment, between the groups. The Tertiary Outcome Measures will be the difference in change in microbial CFUs and clinical signs and symptoms between the groups at the 4 and 6 week point, (2 and 4 weeks after discontinuing treatment), to evaluate if the treatment will produce a lasting effect.
Participants will be randomized into one of the treatment arms. They will use the appropriate treatment for two weeks. They will then be re-assessed. They will discontinue treatment at this time, and four weeks later, will be assessed one last time, to see if the temporary treatment provides a lasting effect. A sub-group of ten patients per group will also be randomized to an extra visit. This group will be assessed after two weeks of having stopped the wipes. The same testing and procedures will be performed at this appointment.
Detailed description
Previous studies have shown the clinical and antimicrobial efficacy of eyelid hygiene with tea tree oil (TTO) in resolving chronic blepharitis. This randomized, outcomes-assessor masked, clinical trial aims to determine the efficacy of Cliradex®, which contains the most active ingredient of (TTO), as compared with I-Lid 'n Lash® Hygiene, in treating chronic blepharitis
Blepharitis is a family of inflammatory disease processes of the eyelid. It can be divided anatomically into anterior and posterior blepharitis. Anterior blepharitis refers to inflammation mainly centered around the eyelashes and follicles, while the posterior variant involves the meibomian gland orifices. Anterior blepharitis usually is subdivided further into staphylococcal and seborrheic variants. Frequently, a considerable overlap exists in these processes in individual patients. Blepharitis often is associated with systemic diseases, such as rosacea and seborrheic dermatitis, as well as ocular diseases, such as dry eye syndromes, chalazion, trichiasis, conjunctivitis, and keratitis.1-3
The pathophysiology of blepharitis involves bacterial colonization of the eyelids. This results in direct microbial invasion of tissues, immune system-mediated damage, or damage caused by the production of bacterial toxins, waste products, and enzymes. Colonization of the lid margin is in-creased in the presence of seborrheic dermatitis or meibomian gland dysfunction.1-3
Blepharitis can be difficult to manage because it is often chronic or tends to recur. Despite the cause, eyelid hygiene is the cornerstone of treatment for most cases of blepharitis. This includes the use of commercially available over-the-counter lid cleansing wipes. Previous studies have shown the clinical and microbial efficacy of lid scrubs with tea tree oil (TTO) in resolving chronic blepharitis; however, lid scrubs based on TTO are not convenient for self-administration and cause irritation in some patients.4-11
Cliradex® (Bio-Tissue, Miami, FL) is a commercially available cosmetic pad containing the most active ingredient of TTO, which also exerts potent anti-microbial effects which may eliminate the need for systemic and/or topical antibiotic therapy for blepharitis.
In this trial, the investigators propose to conduct a randomized, outcomes assessor masked, clinical trial to determine the clinical and antimicrobial efficacy of Cliradex® and I-Lid 'n Lash® Hygiene, in improving the signs and symptoms of blepharitis, as well as decreasing the microbial flora in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a single-centre, randomized, outcomes-assessor masked trial with two groups. Patients with chronic blepharitis will be randomized into either the Cliradex® eyelid hygiene or I-Lid 'n Lash® Hygiene group. There will be 20 participants enrolled in each group. Although both eyes will receive treatment, only the worse eye will be enrolled in the study. In addition to randomizing the participants into treatment group they will also be placed by chance into either the 3 visit or 4 visit group (n=10 per group).
| Arm | Type | Receives |
|---|---|---|
| Cliradex® eyelid hygiene | Experimental | Other: Tea Tree Oil (TTO)Cliradex® is a novel over-the-counter eyelid wipe which contains the most active ingredient of TTO. Previous studies have shown the clinical and antimicrobial efficacy of eyelid hygiene with tea tree oil (TTO) in resolving chronic blepharitis. |
| I-Lid 'n Lash® Hygiene | Other | Other: I-Lid'n Lash® HygieneLid 'n Lash® Hygiene, is an over-the-counter eyelid wipe, without any medicinal ingredients, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with symptomatic blepharitis for duration of at least 3 months.
- Male and female age range: > 18 years old.
- All ethnic groups comparable with the local community.
- Patients able and willing to cooperate with the investigational plan.
- Patients able and willing to complete all postoperative follow-up visits.
Key exclusion criteria (12 listed)
- Patients who are currently engaged in another clinical trial.
- Patients who are unwilling or unable to give consent.
- Patients who are unwilling to accept randomization.
- Patients who will not be able to return for scheduled visits.
- Children under 18.
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 |
|---|---|---|
| Tea Tree Oil (TTO)Participants will use the Cliradex® eyelid hygiene lid wipe / towelette for BID for 2 weeks | Other | Cliradex® eyelid hygiene |
| I-Lid'n Lash® HygienePatients will use the I-Lid'n Lash® Hygiene lid wipe / towelette for BID for 2 weeks | Other | I-Lid 'n Lash® Hygiene |
Primary outcome
Evidence of microbiologic improvement
Time frame: 2 weeks
difference in change in the number of CFU's after 2 weeks treatment, between the groups. (Note: colony counts over 200 will not be counted but reported as >200)
2 secondary outcomes
Improvement in signs & symptoms of blepharitis based on visual grading scale
Time frame: 2 weeks
Improvement in signs & symptoms of blepharitis based on participant questionnaire
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Setareh Ziai, MD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tea Tree Oil (TTO) and I-Lid'n Lash® Hygiene in people with Blepharitis and Meibomian Gland Dysfunction, run by Ottawa Hospital Research Institute 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 12 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: status not confirmed, as of the sponsor's last update on 5 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annelise M Saunders, CCRP (613-737-8657, ansaunders@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of microbiologic improvement (time frame: 2 weeks). 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 5 Feb 2018.