Recruiting

Cliradex® vs. I-Lid'n Lash®

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT03422146

Conditions

Blepharitis

Meibomian Gland Dysfunction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Tea Tree Oil (TTO)

I-Lid'n Lash® Hygiene

Study Details

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

Study ID

NCT03422146

Start date

Feb 19, 2017

Status verified date

Jan, 2018

Completion date

Jan, 2019

Anticipated

Primary completion date

Jan, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cliradex® eyelid hygiene

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: I-Lid 'n Lash® Hygiene

Lid 'n Lash® Hygiene, is an over-the-counter eyelid wipe, without any medicinal ingredients,

Interventions

Tea Tree Oil (TTO)

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

I-Lid'n Lash® Hygiene

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

Primary outcome measure

  • Evidence of microbiologic improvement [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Annelise M Saunders, CCRP

613-737-8657ansaunders@toh.ca

Melanie Lalonde, PhD

613-737-8519mlalonde@ohri.ca

Locations

Ottawa Health Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Annelise M Saunders, CCRP

613-737-8657ansaunders@toh.ca

Principal Investigator:

Setareh Ziai, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Feb 5, 2018

Last verified

Jan, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2018-02-05.