Myopia
Conditions
Keywords
Contact Lenses
Brief summary
This open-label study is of current Acuvue® Oasys® wearers (2 - week replacement, reusable lenses) who are satisfied with their current lenses. Subjects will be refit into one week reusable contact lenses and will wear lenses for approximately 2 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience.
Interventions
DEVICEBiweekly replacement contact lenses
Biweekly replacement reusable contact lenses.
DEVICEOne week replacement contact lenses
One week replacement reusable contact lenses.
Sponsors
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will be fit into Acuvue Oasys contact lenses at the first visit to wear for 2 weeks. Subjects will then be fit into PRECISION7 lenses at the second visit to wear for 2 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. At least 18 years of age 2. Ability to give informed consent 3. Current Acuvue® Oasys® spherical lens wearer. 4. Distance visual acuity of 20/25 or better with current contact lenses in each eye. 5. Good general health defined by, medication use that has not changed within the last 30 days and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the Investigator. 6. Willing to spend time for the study, which includes: attend three study visits and wear contact lenses on days between study visits.
Exclusion criteria
1. Current or active ocular inflammation or infection as determined by the Investigator. 2. Currently pregnant or lactating. (Participants will be asked to self-report these conditions). 3. Systemic inflammatory disease (i.e. Diabetes, etc.) that could confound study results in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Assessment of Lens Wear Experience | After 2 weeks of wear in the 1-week replacement reusable lenses. | Subjective assessment of lens wear experience using a CLDEQ-8 survey (contact lens dry eye questionnaire). There are 8 questions about about the presence and intensity of symptoms when wearing contact lenses. When totaling the scores for each question, the lowest possible score=1 and the highest possible score=37. Higher scores result from more prevalent and intense symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Contact Lens Wear Experience Participants will be enrolled in the study for 4 weeks. Biweekly replacement contact lenses will be worn for the first 2 weeks. One-week replacement lenses worn for second 2 weeks.
Biweekly replacement contact lenses: Biweekly replacement reusable contact lenses.
One week replacement contact lenses: One week replacement reusable contact lenses. | 62 |
| Total | 62 |
Baseline characteristics
| Characteristic | Contact Lens Wear Experience |
|---|---|
| Age, Continuous | 28.9 years STANDARD_DEVIATION 5.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 4 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 | 44 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 62 |
| other Total, other adverse events | 0 / 62 |
| serious Total, serious adverse events | 0 / 62 |
Outcome results
Primary
Subjective Assessment of Lens Wear Experience
Subjective assessment of lens wear experience using a CLDEQ-8 survey (contact lens dry eye questionnaire). There are 8 questions about about the presence and intensity of symptoms when wearing contact lenses. When totaling the scores for each question, the lowest possible score=1 and the highest possible score=37. Higher scores result from more prevalent and intense symptoms.
Time frame: After 2 weeks of wear in the 1-week replacement reusable lenses.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Contact Lens Wear Experience | Subjective Assessment of Lens Wear Experience | 10 Scores on a scale |