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

University of Waterloo

Status: Completed

Conditions: Dry Eye

Treatments: Other: Blephadex Lid Wipes; Other: I-LID N LASH PLUS® Eyelid Cleanser; Other: Blephademodex; Drug: Sensitive Eyes® Plus Saline Solution; Other: Eye Cleanse Lid Wipes; Other: Oust™ Demodex® Wipes™

Study type: Interventional

Funder types: Other

Identifiers

NCT03987230

40995

Details and patient eligibility

About

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

Enrollment: 17 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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17 participants in 6 patient groups, including a placebo group

Oust™ Demodex® Wipes™

Active Comparator group

Description:

Participant cleans eyelids with Oust™ Demodex® Wipes™

Treatment:

Other: Oust™ Demodex® Wipes™

I-LID N LASH PLUS® Eyelid Cleanser

Active Comparator group

Description:

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

Treatment:

Other: I-LID N LASH PLUS® Eyelid Cleanser

Blephadex Lid Wipes

Active Comparator group

Description:

Participant cleans eyelids with Blephadex Lid Wipes

Treatment:

Other: Blephadex Lid Wipes

Eye Cleanse Lid Wipes

Active Comparator group

Description:

Participant cleans eyelids with Eye Cleanse Lid Wipes

Treatment:

Other: Eye Cleanse Lid Wipes

Blephademodex

Active Comparator group

Description:

Participant cleans eyelids with Blephademodex

Treatment:

Other: Blephademodex

Sensitive Eyes® Plus Saline Solution

Placebo Comparator group

Description:

Participant cleans eyelids with Sensitive Eyes® Plus Saline Solution

Treatment:

Drug: Sensitive Eyes® Plus Saline Solution