Comfort Associated With The Use Of Eyelid Cleansing Produ... | NCT03987230

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oust™ Demodex® Wipes™	Active Comparator	Participant cleans eyelids with Oust™ Demodex® Wipes™	Other: Oust™ Demodex® Wipes™
I-LID N LASH PLUS® Eyelid Cleanser	Active Comparator	Participant cleans eyelids with I-LID N LASH PLUS® Eyelid Cleanser	Other: I-LID N LASH PLUS® Eyelid Cleanser
Blephadex Lid Wipes	Active Comparator	Participant cleans eyelids with Blephadex Lid Wipes	Other: Blephadex Lid Wipes
Eye Cleanse Lid Wipes	Active Comparator	Participant cleans eyelids with Eye Cleanse Lid Wipes	Other: Eye Cleanse Lid Wipes
Blephademodex	Active Comparator	Participant cleans eyelids with Blephademodex	Other: Blephademodex
Sensitive Eyes® Plus Saline Solution	Placebo Comparator	Participant cleans eyelids with Sensitive Eyes® Plus Saline Solution

Name	Type	Description	Arm Group Labels	Other Names
Sensitive Eyes® Plus Saline Solution	Drug	Sensitive Eyes® Plus Saline Solution	Sensitive Eyes® Plus Saline Solution

Outcomes Module

Primary Outcomes

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

Eligibility Module

Eligibility Criteria

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.

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations