An interventional study of Tea Tree Oil (TTO) and I-Lid'n Lash® Hygiene in Blepharitis and Meibomian Gland Dysfunction, sponsored by Ottawa Hospital Research Institute. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-05.
Sponsored by Ottawa Hospital Research Institute · Not applicable, Interventional, and Treatment
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.
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.
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 65 interventional studies indexed under Blepharitis.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Tea Tree Oil (TTO)
Lid 'n Lash® Hygiene, is an over-the-counter eyelid wipe, without any medicinal ingredients,
Other: I-Lid'n Lash® Hygiene
Participants will use the Cliradex® eyelid hygiene lid wipe / towelette for BID for 2 weeks
Patients will use the I-Lid'n Lash® Hygiene lid wipe / towelette for BID for 2 weeks
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)
Time frame: 2 weeks
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
Time frame: 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.
Time frame: 2 weeks
Evidence of continued microbiologic improvement after discontinuing blepharitis treatment
difference in change in the number of CFU's at 2 \& 4 weeks post discontinuation of treatment, between the groups. (Note: colony counts over 200 will not be counted but reported as \>200)
Time frame: 2 & 4 weeks post discontinuation of treatment
Evidence of continued improvement in signs & symptoms of blepharitis, based on grading scale, after discontinuing blepharitis treatment
The Outcome Measure will be the difference in change in objective clinical signs and symptoms using a visual grading scale
Time frame: 2 & 4 weeks post discontinuation of treatment
Evidence of continued improvement in signs & symptoms of blepharitis, based on participant questionnaire, after discontinuing blepharitis treatment
The Outcome Measure will be the difference in change in objective clinical signs and symptoms using a questionnaire
Time frame: 2 & 4 weeks post discontinuation of treatment
Plan to share: No
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Started Feb 2017 (actual). Primary completion is estimated for Jan 2019, 23 months after the start.
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