Antimicrobial and Clinical Efficacy of Cliradex® as Compared With I-Lid'n Lash® Hygiene in Treating Blepharitis

NCT03422146 | Unknown

• 1 other identifier: P20130792-01H
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Blepharitis; Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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)

  2 weeks

Secondary Outcomes (2)

• Improvement in signs & symptoms of blepharitis based on visual grading scale

  2 weeks

• Improvement in signs & symptoms of blepharitis based on participant questionnaire

  2 weeks

Other Outcomes (3)

• Evidence of continued microbiologic improvement after discontinuing blepharitis treatment

  2 & 4 weeks post discontinuation of treatment

• Evidence of continued improvement in signs & symptoms of blepharitis, based on grading scale, after discontinuing blepharitis treatment

  2 & 4 weeks post discontinuation of treatment

• Evidence of continued improvement in signs & symptoms of blepharitis, based on participant questionnaire, after discontinuing blepharitis treatment

  2 & 4 weeks post discontinuation of treatment

Study Arms (2)

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.

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,

Other: I-Lid'n Lash® Hygiene

Interventions

Tea Tree Oil (TTO) OTHER

Participants will use the Cliradex® eyelid hygiene lid wipe / towelette for BID for 2 weeks

Cliradex® eyelid hygiene

I-Lid'n Lash® Hygiene OTHER

Patients will use the I-Lid'n Lash® Hygiene lid wipe / towelette for BID for 2 weeks

I-Lid 'n Lash® Hygiene

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Health Research Institute

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

MeSH Terms

Conditions

Blepharitis; Meibomian Gland Dysfunction

Interventions

Tea Tree Oil

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Oils, Volatile; Oils; Lipids; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Setareh Ziai, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annelise M Saunders, CCRP

CONTACT

613-737-8657; ansaunders@toh.ca

Melanie Lalonde, PhD

CONTACT

613-737-8519; mlalonde@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * Information concerning the group the patient was randomized into will not be available to the physicians that will see the participants at future appointments and grade their outcomes (masked assessor). * All microbiology readers will be masked to treatment group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: February 5, 2018
• Study Start: February 19, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: February 5, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)