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

Study Overview
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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.

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

Conditions
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Dry Eye

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is between the ages of 18 to 60 and has the full legal capacity to volunteer; Has read and signed an informed consent letter; Agrees to refrain from the use of ocular lubricants during the study period; Agrees to not to use eye-related cosmetics for upcoming study visits Is willing to use the study products Is willing and able to follow instructions regarding study procedures and maintain the appointment schedule; Has corneal sensitivity within physiological limits. Exclusion Criteria: Is participating in any concurrent clinical or research study; Is a contact lens wearer (due to reduced corneal sensitivity); Has any known active* ocular disease and/or infection; including moderate and severe dry eye (OSDI ≥ 23); 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; 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; 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; 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 Has undergone refractive error surgery (e.g. LASIK, PRK); 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each participant receives 6 different interventions in random order
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oust™ Demodex® Wipes™<br>Participant cleans eyelids with Oust™ Demodex® Wipes™ | Other: Oust™ Demodex® Wipes™<br>* Oust™ Demodex® Wipes™<br>|
| Active Comparator: I-LID N LASH PLUS® Eyelid Cleanser<br>Participant cleans eyelids with I-LID N LASH PLUS® Eyelid Cleanser | Other: I-LID N LASH PLUS® Eyelid Cleanser<br>* I-LID N LASH PLUS® Eyelid Cleanser<br>|
| Active Comparator: Blephadex Lid Wipes<br>Participant cleans eyelids with Blephadex Lid Wipes | Other: Blephadex Lid Wipes<br>* Blephadex Lid Wipes<br>|
| Active Comparator: Eye Cleanse Lid Wipes<br>Participant cleans eyelids with Eye Cleanse Lid Wipes | Other: Eye Cleanse Lid Wipes<br>* Eye Cleanse Lid Wipes<br>|
| Active Comparator: Blephademodex<br>Participant cleans eyelids with Blephademodex | Other: Blephademodex<br>* Blephademodex<br>|
| Placebo Comparator: Sensitive Eyes® Plus Saline Solution<br>Participant cleans eyelids with Sensitive Eyes® Plus Saline Solution | Drug: Sensitive Eyes® Plus Saline Solution<br>* Sensitive Eyes® Plus Saline Solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant's Subjective discomfort - Baseline | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | Baseline | 
| Participant's Subjective discomfort - 0 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | Immediately after application | 
| Participant's Subjective discomfort - 15 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 15 seconds after application | 
| Participant's Subjective discomfort - 30 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 30 seconds after application | 
| Participant's Subjective discomfort - 45 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 45 seconds after application | 
| Participant's Subjective discomfort - 60 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 60 seconds after application | 
| Participant's Subjective discomfort - 75 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 75 seconds after application | 
| Participant's Subjective discomfort - 90 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 90 seconds after application | 
| Participant's Subjective discomfort - 105 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 105 seconds after application | 
| Participant's Subjective discomfort - 120 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 120 seconds after application | 
| Participant's Subjective discomfort - 135 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 135 seconds after application | 
| Participant's Subjective discomfort - 150 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 150 seconds after application | 
| Participant's Subjective discomfort - 165 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 165 seconds after application | 
| Participant's Subjective discomfort - 180 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 180 seconds after application | 
| Participant's Subjective discomfort - 195 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 195 seconds after application | 
| Participant's Subjective discomfort - 210 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 210 seconds after application | 
| Participant's Subjective discomfort - 225 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 225 seconds after application | 
| Participant's Subjective discomfort - 240 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 240 seconds after application | 
| Participant's Subjective discomfort - 255 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 255 seconds after application | 
| Participant's Subjective discomfort - 270 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 270 seconds after application | 
| Participant's Subjective discomfort - 285 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 285 seconds after application | 
| Participant's Subjective discomfort - 300 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 300 seconds after application | 
| Participant's Subjective discomfort - 330 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 330 seconds after application | 
| Participant's Subjective discomfort - 360 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 360 seconds after application | 
| Participant's Subjective discomfort - 390 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 390 seconds after application | 
| Participant's Subjective discomfort - 420 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 420 seconds after application | 
| Participant's Subjective discomfort - 450 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 450 seconds after application | 
| Participant's Subjective discomfort - 480 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 480 seconds after application | 
| Participant's Subjective discomfort - 510 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 510 seconds after application | 
| Participant's Subjective discomfort - 540 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 540 seconds after application | 
| Participant's Subjective discomfort - 570 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 570 seconds after application | 
| Participant's Subjective discomfort - 600 seconds after application | Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort) | 600 seconds after application | 
| Time to comfortably open the eyes after the application of eyelid cleansing wipe | Time to comfortably open the eyes after the application of eyelid cleansing wipe in seconds | Between 0 and 600 seconds after application |