Contact Lens
Conditions
Brief summary
The purpose of this study is to assess the wear experience of existing wearers of a monthly replacement contact lens after they have been fit with a daily disposable contact lens that has water surface treatment.
Interventions
Monthly replacement contact lenses
DEVICEVerofilcon A for Astigmatism Daily Disposable contact lenses
Daily disposable contact lenses
Sponsors
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
* Must be a current wearer of Comfilcon A 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 three study visits and be willing to wear contact lenses on days between study visits. * Either gender. * Any racial or ethnic origin.
Exclusion criteria
* No current ocular inflammation or infection. * Not currently pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Assessment of Overall Comfort With Verofilcon A Daily Disposable Lenses for Astigmatism | 3 weeks | Participants will complete a Visual Analog Scale survey of overall comfort (0-100 Scale with 0 anchored with Poor Comfort and 100 anchored as Excellent Comfort) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Habitual Lens Optimization Followed by Refitting With Study Lenses All participants are re-fit with habitual Biofinity Toric lenses to optimize vision. Lenses were worn for 2 weeks before returning to be refit with daily disposable lenses with water surface treatment. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Habitual Lens Optimization Followed by Refitting With Study Lenses |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 27.2 years STANDARD_DEVIATION 4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 4 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 | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 1 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Subjective Assessment of Overall Comfort With Verofilcon A Daily Disposable Lenses for Astigmatism
Participants will complete a Visual Analog Scale survey of overall comfort (0-100 Scale with 0 anchored with Poor Comfort and 100 anchored as Excellent Comfort)
Time frame: 3 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Habitual Lens Optimization Followed by Refitting With Study Lenses | Subjective Assessment of Overall Comfort With Verofilcon A Daily Disposable Lenses for Astigmatism | 91 units on a scale |