Trial Outcomes & Findings for Wear Experience With Daily Toric Contact Lenses Over a Long Day (NCT NCT04844281)
NCT ID: NCT04844281
Last Updated: 2023-11-29
Results Overview
1 describes poor experience, and 10 describes excellent experience.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Assessment is taken at the 16 hour of wear time point in a single day, after up to 14 days of wear.
Results posted on
2023-11-29
Participant Flow
Participant milestones
| Measure |
Daily Disposable Toric Contact Lens
All subjects are fit into Precision1® toric contact lenses. Subjects are requested to wear the lenses for a total of two weeks.
Precision1® Daily Disposable Toric Contact Lens: Soft, toric contact lens used to correct distance vision and astigmatism.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Wear Experience With Daily Toric Contact Lenses Over a Long Day
Baseline characteristics by cohort
| Measure |
Daily Disposable Toric Contact Lens
n=30 Participants
All subjects are fit into Precision1® toric contact lenses. Subjects are requested to wear the lenses for a total of two weeks.
Precision1® Daily Disposable Toric Contact Lens: Soft, toric contact lens used to correct distance vision and astigmatism.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
28.4 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessment is taken at the 16 hour of wear time point in a single day, after up to 14 days of wear.1 describes poor experience, and 10 describes excellent experience.
Outcome measures
| Measure |
Daily Disposable Toric Contact Lens
n=30 Participants
All subjects are fit into Precision1® toric contact lenses. Subjects are requested to wear the lenses for a total of two weeks.
Precision1® Daily Disposable Toric Contact Lens: Soft, toric contact lens used to correct distance vision and astigmatism.
|
|---|---|
|
Subjective Vision in Contact Lenses Assessed Using a 1 to 10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)
|
9 units on a scale
Interval 7.0 to 10.0
|
PRIMARY outcome
Timeframe: Taken at the 16 hour of wear time point in a single day, after up to 14 days of wear Up to 14 days1 describes poor experience, and 10 describes excellent experience.
Outcome measures
| Measure |
Daily Disposable Toric Contact Lens
n=30 Participants
All subjects are fit into Precision1® toric contact lenses. Subjects are requested to wear the lenses for a total of two weeks.
Precision1® Daily Disposable Toric Contact Lens: Soft, toric contact lens used to correct distance vision and astigmatism.
|
|---|---|
|
Subjective Comfort on a 1-10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)
|
8.4 units on a scale
Interval 7.0 to 9.0
|
Adverse Events
Daily Disposable Toric 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, OD MS
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