Trial Outcomes & Findings for Evaluation of Wear Experience With Daily Contact Lenses (NCT NCT05096156)

Last Updated: 2023-11-08

Results Overview

Contact Lens Dry Eye Questionnaire (CLDEQ) survey (0-37, with higher scores related to higher symptoms)

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

2 weeks

Results posted on

2023-11-08

Participant milestones
Measure	All Participants Are Fit With the Study Daily Disposable Lenses All subjects are re-fit into their habitual monthly replacement contact lenses. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days. Upon return, subjects are refit into the daily disposable contact lenses. Precision1® Daily Disposable Contact Lens: Soft, spherical contact lens used to correct distance vision.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Evaluation of Wear Experience With Daily Contact Lenses

Baseline characteristics by cohort
Measure	All Participants Are Fit With the Study Daily Disposable Lenses n=30 Participants All subjects are re-fit into their habitual monthly replacement contact lenses. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days. Upon return, subjects are refit into the daily disposable contact lenses. 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	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	30.5 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

Timeframe: 2 weeks

Contact Lens Dry Eye Questionnaire (CLDEQ) survey (0-37, with higher scores related to higher symptoms)

Outcome measures
Measure	All Participants Are Fit With the Study Daily Disposable Lenses n=30 Participants All subjects are re-fit into their habitual monthly replacement contact lenses. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days. Upon return, subjects are refit into the daily disposable contact lenses. Precision1® Daily Disposable Contact Lens: Soft, spherical contact lens used to correct distance vision.
Subjective Assessment of Precision1® Daily Disposable Contact Lens	6.5 units on a scale Interval 3.0 to 10.0

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

The Ohio State University College of Optometry

Phone: 16142928858