Contact Lens
Conditions
Keywords
Daily Disposable Contact Lens, Spherical Contact Lens, Soft Contact Lens
Brief summary
This study is evaluating the wear experience of a daily contact lens after 10, 12, 14, and 16 hours of lens wear.
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
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Must be a current spherical contact lens wearer with longs days of lens wear. * 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). * Recent eye exam within the past year. * Must have a working smart phone and be willing to download an app and/or receive and respond to texts. * Ability to give informed consent. * Willing to spend time for the study. Subjects will be required to attend three study visits, wear contact lenses on days between study visits, and must respond to push-notifications and/or texts on a smart phone for 5 days between visits 2 and 3.
Exclusion criteria
* No current ocular inflammation or infection as assessed by the study investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Overall Comfort as Assessed Using the Visual Analog Scale (VAS) | Up to 14 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Daily Disposable Contact Lens |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants |
| Age, Continuous | 25.6 years STANDARD_DEVIATION 4.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Region of Enrollment United States | 35 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
Subjective Overall Comfort as Assessed Using the Visual Analog Scale (VAS)
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.
Time frame: Up to 14 days
Population: participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Daily Disposable Contact Lens | Subjective Overall Comfort as Assessed Using the Visual Analog Scale (VAS) | 93 units on a scale |