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

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

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

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 days

1 describes poor experience, and 10 describes excellent experience.

Outcome measures

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

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place