Comfort Associated With The Use Of Eyelid Cleansing Products Available For The Management Of Demodex Folliculorum

NCT ID: NCT03987230

Last Updated: 2019-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-29

Study Completion Date

2019-06-18

Brief Summary

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This aim of this study to quantify the subjective ocular awareness of different eyelid cleansing wipes available for the management of Demodex folliculorum.

Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each participant receives 6 different interventions in random order
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oust™ Demodex® Wipes™

Participant cleans eyelids with Oust™ Demodex® Wipes™

Group Type ACTIVE_COMPARATOR

Oust™ Demodex® Wipes™

Intervention Type OTHER

Oust™ Demodex® Wipes™

I-LID N LASH PLUS® Eyelid Cleanser

Participant cleans eyelids with I-LID N LASH PLUS® Eyelid Cleanser

Group Type ACTIVE_COMPARATOR

I-LID N LASH PLUS® Eyelid Cleanser

Intervention Type OTHER

I-LID N LASH PLUS® Eyelid Cleanser

Blephadex Lid Wipes

Participant cleans eyelids with Blephadex Lid Wipes

Group Type ACTIVE_COMPARATOR

Blephadex Lid Wipes

Intervention Type OTHER

Blephadex Lid Wipes

Eye Cleanse Lid Wipes

Participant cleans eyelids with Eye Cleanse Lid Wipes

Group Type ACTIVE_COMPARATOR

Eye Cleanse Lid Wipes

Intervention Type OTHER

Eye Cleanse Lid Wipes

Blephademodex

Participant cleans eyelids with Blephademodex

Group Type ACTIVE_COMPARATOR

Blephademodex

Intervention Type OTHER

Blephademodex

Sensitive Eyes® Plus Saline Solution

Participant cleans eyelids with Sensitive Eyes® Plus Saline Solution

Group Type PLACEBO_COMPARATOR

Sensitive Eyes® Plus Saline Solution

Intervention Type DRUG

Sensitive Eyes® Plus Saline Solution

Interventions

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Sensitive Eyes® Plus Saline Solution

Sensitive Eyes® Plus Saline Solution

Intervention Type DRUG

Oust™ Demodex® Wipes™

Oust™ Demodex® Wipes™

Intervention Type OTHER

I-LID N LASH PLUS® Eyelid Cleanser

I-LID N LASH PLUS® Eyelid Cleanser

Intervention Type OTHER

Blephadex Lid Wipes

Blephadex Lid Wipes

Intervention Type OTHER

Eye Cleanse Lid Wipes

Eye Cleanse Lid Wipes

Intervention Type OTHER

Blephademodex

Blephademodex

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Is between the ages of 18 to 60 and has the full legal capacity to volunteer;
2. Has read and signed an informed consent letter;
3. Agrees to refrain from the use of ocular lubricants during the study period;
4. Agrees to not to use eye-related cosmetics for upcoming study visits
5. Is willing to use the study products
6. Is willing and able to follow instructions regarding study procedures and maintain the appointment schedule;
7. Has corneal sensitivity within physiological limits.

Exclusion Criteria

1. Is participating in any concurrent clinical or research study;
2. Is a contact lens wearer (due to reduced corneal sensitivity);
3. Has any known active\* ocular disease and/or infection; including moderate and severe dry eye (OSDI ≥ 23);
4. Has a systemic (such as diabetes, thyroid disease, rheumatoid arthritis) or ocular condition (such as glaucoma) that in the opinion of the investigator may affect a study outcome variable;
5. Is using any systemic or topical medications (such as glaucoma drops, antibiotics, anti-inflammatory) that in the opinion of the investigator may affect a study outcome variable;
6. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study (such as fluorescein dye to highlight structures of the eye and used regularly in optometric practice) and study products in this study;
7. Is pregnant, lactating or planning a pregnancy at the time of enrolment; (due to the possibility of fluctuating vision as a consequence of variation in hormone levels);8
8. Has undergone refractive error surgery (e.g. LASIK, PRK);
9. Is a smoker (as smoking reduces tear film stability) \* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye (Ocular Surface Disease Index, OSDI\<23/100) are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Waterloo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre for Ocular Research & Education

Waterloo, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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40995

Identifier Type: -

Identifier Source: org_study_id

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