Trial Outcomes & Findings for Product Testing of the FaceView Mask™: Usability Survey (NCT NCT04854694)
NCT ID: NCT04854694
Last Updated: 2025-04-10
Results Overview
As recorded on the survey 1. Difficult 2. Somewhat difficult 3. Somewhat easy 4. Easy
Recruitment status
COMPLETED
Target enrollment
202 participants
Primary outcome timeframe
1 day
Results posted on
2025-04-10
Participant Flow
Participant milestones
| Measure |
Transparent Mask First, Then Non-Transparent Mask
Participants completed fit testing protocol using the transparent mask first, followed by the same fit testing protocol with a non-transparent mask, then completed a questionnaire.
|
Non-Transparent Mask First, Then Transparent Mask
Participants completed fit testing protocol using the non-transparent mask first, followed by the same fit testing protocol with a transparent mask, then completed a questionnaire.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
101
|
|
Overall Study
COMPLETED
|
101
|
101
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant identified as Intersex
Baseline characteristics by cohort
| Measure |
All Subjects
n=202 Participants
All participants will be fit tested for the masks to ensure that the appropriate size is used. Some participants will wear the FaceView Mask™ (first) for 5 minutes before wearing the conventional surgical N95 respirator for 5 minutes. Others will wear the conventional surgical N95 respirator (first) for 5 minutes before wearing the FaceView Mask™ for 5 minutes.
All subjects will complete the study survey after exposure to the interventions.
FaceView Mask™: transparent surgical N95 respirator designed to improve communication
conventional surgical N95 respirator: standard N95 respirator
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=202 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
198 Participants
n=202 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=202 Participants
|
|
Age, Continuous
|
34.3 years
n=202 Participants
|
|
Sex/Gender, Customized
Female
|
173 Participants
n=202 Participants
|
|
Sex/Gender, Customized
Male
|
28 Participants
n=202 Participants
|
|
Sex/Gender, Customized
Intersex
|
1 Participants
n=202 Participants
|
|
Sex/Gender, Customized
Prefer Not to Say
|
0 Participants
n=202 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=201 Participants • One participant identified as Intersex
|
|
Sex: Female, Male
Male
|
28 Participants
n=201 Participants • One participant identified as Intersex
|
PRIMARY outcome
Timeframe: 1 dayAs recorded on the survey 1. Difficult 2. Somewhat difficult 3. Somewhat easy 4. Easy
Outcome measures
| Measure |
Transparent Mask
n=202 Participants
Wore FaceView Mask which is the transparent mask
|
Non-Transparent Mask
n=202 Participants
Wore 3M N95 mask which is the non-transparent mask
|
|---|---|---|
|
Ease of Understanding Another Person
Difficult
|
0 Participants
|
24 Participants
|
|
Ease of Understanding Another Person
Somewhat difficult
|
4 Participants
|
67 Participants
|
|
Ease of Understanding Another Person
Somewhat easy
|
36 Participants
|
47 Participants
|
|
Ease of Understanding Another Person
Easy
|
162 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: 1 dayAs recorded on the survey 1. Extremely small 2. Slightly too small 3. Fits well 4. Slightly too large 5. Extremely large
Outcome measures
| Measure |
Transparent Mask
n=202 Participants
Wore FaceView Mask which is the transparent mask
|
Non-Transparent Mask
n=202 Participants
Wore 3M N95 mask which is the non-transparent mask
|
|---|---|---|
|
Fit of the Mask
Extremely small
|
2 Participants
|
4 Participants
|
|
Fit of the Mask
Slightly too small
|
7 Participants
|
29 Participants
|
|
Fit of the Mask
Fits well
|
172 Participants
|
142 Participants
|
|
Fit of the Mask
Slightly too large
|
21 Participants
|
27 Participants
|
|
Fit of the Mask
Extremely large
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 dayAs recorded on the survey 1. Not comfortable at all 2. Slightly comfortable 3. Very comfortable 4. Extremely comfortable
Outcome measures
| Measure |
Transparent Mask
n=202 Participants
Wore FaceView Mask which is the transparent mask
|
Non-Transparent Mask
n=202 Participants
Wore 3M N95 mask which is the non-transparent mask
|
|---|---|---|
|
Comfort of the Mask
Not comfortable at all
|
2 Participants
|
31 Participants
|
|
Comfort of the Mask
Slightly comfortable
|
46 Participants
|
110 Participants
|
|
Comfort of the Mask
Very comfortable
|
115 Participants
|
53 Participants
|
|
Comfort of the Mask
Extremely comfortable
|
39 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 1 dayAs recorded on the survey 1. Not easy at all 2. Slightly breathable 3. Very breathable 4. Extremely breathable
Outcome measures
| Measure |
Transparent Mask
n=202 Participants
Wore FaceView Mask which is the transparent mask
|
Non-Transparent Mask
n=202 Participants
Wore 3M N95 mask which is the non-transparent mask
|
|---|---|---|
|
Ease of Breathing
Slightly breathable
|
31 Participants
|
85 Participants
|
|
Ease of Breathing
Very breathable
|
123 Participants
|
81 Participants
|
|
Ease of Breathing
Not easy at all
|
1 Participants
|
25 Participants
|
|
Ease of Breathing
Extremely breathable
|
47 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 1 dayAs recorded on the survey 1. Difficult 2. Somewhat difficult 3. Somewhat easy 4. Easy
Outcome measures
| Measure |
Transparent Mask
n=202 Participants
Wore FaceView Mask which is the transparent mask
|
Non-Transparent Mask
n=202 Participants
Wore 3M N95 mask which is the non-transparent mask
|
|---|---|---|
|
Ease of Speaking/Communicating
Somewhat easy
|
36 Participants
|
64 Participants
|
|
Ease of Speaking/Communicating
Easy
|
157 Participants
|
54 Participants
|
|
Ease of Speaking/Communicating
Difficult
|
0 Participants
|
20 Participants
|
|
Ease of Speaking/Communicating
Somewhat difficult
|
9 Participants
|
64 Participants
|
Adverse Events
Transparent Mask
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Transparent Mask
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place