Contact Lens
Conditions
Brief summary
To evaluate the wear experience of current monthly replacement contact lens wearers after they have been fit into a daily disposable contact lens.
Interventions
Soft, spherical contact lens used to correct distance vision.
Sponsors
Alcon Research
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Currently wear Biofinity® monthly replacement spherical contact lenses. * Distance visual acuity of 20/25 or better with current contact lenses. * Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI). * Ability to give informed consent. * Willing to spend time for the study, which includes attending two study visits and wearing contact lenses on days between study visits.
Exclusion criteria
* No current ocular inflammation or infection. * Not currently pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Assessment of Precision1® Daily Disposable Contact Lens | 2 weeks | Contact Lens Dry Eye Questionnaire (CLDEQ) survey (0-37, with higher scores related to higher symptoms) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Participants Are Fit With the Study Daily Disposable Lenses |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 30.5 years STANDARD_DEVIATION 6.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Subjective Assessment of Precision1® Daily Disposable Contact Lens
Contact Lens Dry Eye Questionnaire (CLDEQ) survey (0-37, with higher scores related to higher symptoms)
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants Are Fit With the Study Daily Disposable Lenses | Subjective Assessment of Precision1® Daily Disposable Contact Lens | 6.5 units on a scale |