Trial Outcomes & Findings for Wear Experience With Daily Contact Lenses Over a Long Day (NCT NCT04535310)
NCT ID: NCT04535310
Last Updated: 2023-02-08
Results Overview
Subjective overall comfort as assessed using the Visual Analog Scale (VAS), with a scale of 0 to 100 with 0 being poor and 100 being excellent.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Up to 14 days
Results posted on
2023-02-08
Participant Flow
Participant milestones
| Measure |
Daily Disposable Contact Lens
All subjects are fit into Precision1® contact lenses. Subjects are requested to wear the lenses for a total of two weeks.
Precision1® Daily Disposable Contact Lens: Soft, spherical contact lens used to correct distance vision.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Wear Experience With Daily Contact Lenses Over a Long Day
Baseline characteristics by cohort
| Measure |
Daily Disposable Contact Lens
n=35 Participants
All subjects are fit into Precision1® contact lenses. Subjects are requested to wear the lenses for a total of two weeks.
Precision1® Daily Disposable Contact Lens: Soft, spherical contact lens used to correct distance vision.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25.6 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 14 daysPopulation: participants
Subjective overall comfort as assessed using the Visual Analog Scale (VAS), with a scale of 0 to 100 with 0 being poor and 100 being excellent.
Outcome measures
| Measure |
Daily Disposable Contact Lens
n=35 Participants
All subjects are fit into Precision1® contact lenses. Subjects are requested to wear the lenses for a total of two weeks.
Precision1® Daily Disposable Contact Lens: Soft, spherical contact lens used to correct distance vision.
|
|---|---|
|
Subjective Overall Comfort as Assessed Using the Visual Analog Scale (VAS)
|
93 units on a scale
Interval 82.5 to 99.0
|
Adverse Events
Daily Disposable Contact Lens
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
Jennifer Fogt
The Ohio State University College of Optometry
Phone: 16142928858
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place