Contact Lens
Conditions
Keywords
Daily Disposable Contact Lens, Soft Contact Lens, Spherical Contact Lens
Brief summary
To evaluate the wear experience of current two-week contact lens wearers after they have been fit into a daily disposable contact lens. This is a single arm, non-comparative study.
Detailed description
This is a single arm, non-comparative study. All participants were habitual lens wearers of the same brand of lenses, and were re-fit with the study lenses.
Interventions
Soft, daily disposable 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
Intervention model description
This is a single arm, non-comparative study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Must be current Acuvue® Oasys® spherical contact lens wearers. * 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. * 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 |
|---|---|---|
| Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey | 2 weeks | Participants complete the Contact Lens Dry Eye Questionnaire (CLDEQ-8) survey. This is an 8 question survey assesses symptoms while wearing contact lenses with possible scores from 0 (no symptoms) to 37 (maximum symptoms). Higher scores indicate worsening symptoms of dry eye while wearing lenses. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Wear Study Daily Disposable Contact Lenses All subjects are re-fit into their habitual reusable soft contact lenses to optimize vision. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days.
Subjects then return and are fit with the daily disposable soft contact lens. After wearing the daily disposable lenses, participants return to assess vision and lens fit and answer surveys about their experience. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Participants Wear Study Daily Disposable Contact Lenses |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 29.1 years STANDARD_DEVIATION 7.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 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 | 25 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 11 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
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey
Participants complete the Contact Lens Dry Eye Questionnaire (CLDEQ-8) survey. This is an 8 question survey assesses symptoms while wearing contact lenses with possible scores from 0 (no symptoms) to 37 (maximum symptoms). Higher scores indicate worsening symptoms of dry eye while wearing lenses.
Time frame: 2 weeks
Population: All subjects were in the same arm, and wore both types of lenses. This was not a comparative study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Study Participants | Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey | 9.5 units on a scale |