Presbyopia
Conditions
Keywords
contact lenses, Multifocal contact lenses
Brief summary
To explore the wear experience in Dailies TOTAL1 Multifocal contact lenses in presbyopic adults who have previously dropped out of contact lens wear.
Detailed description
The purpose of this study is to evaluate the wear experience of people with presbyopia who previously dropped out of contact lens wear when fit with a Delefilcon A soft lens multifocal lens. Investigators expect to enroll a relatively equal amount of former soft multifocal contact lens wearers who dropped out due to poor vision at distance or near and single vision wearers who dropped out due to poor near vision. The key endpoints include Visual Analog Scale survey of lens wear symptoms (comfort, dryness, vision) with contact lenses and assessment of the participant's quality of life with the Dailies TOTAL1 Multifocal® contact lenses.
Interventions
DEVICEDaily disposable multifocal soft contact lens
Daily disposable multifocal soft contact lens that will be worn for 1 month.
Sponsors
Alcon Research
Jennifer Fogt
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
38 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Ability to give informed consent. * Any gender. * Any racial or ethnic origin. * At least 38 years of age or older. * Willing to spend time for the study. Three visits are required to complete the study, and additional follow up visits could be scheduled if needed. * Subjects must have corrected distance visual acuity in both eyes equivalent to 20/25 or better at the screening visit. * Spectacle sphere power range between +6.00 to -10.00. * Previously dropped out of contact lens wear due to vision or vision and discomfort. * 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
Exclusion criteria
* Current or active ocular inflammation or infection as determined by the Investigator. * Astigmatism ≥ 1.00 D in either eye. * History of previous eye surgery. * Strabismus or binocular vision abnormalities that prevent completion of testing, at the discretion of the Investigator. * Demonstration or history of corneal ectasia or keratoconus. * Pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | 1 month | Visual Analog Scale survey of lens wear symptoms (vision) with contact lenses; percentage of participants with positive scores (\> 50). |
| Quality of Life Survey | 1 month | Assessment of the participant's quality of life with the daily disposable multifocal contact lenses; percentage of participants with VAS scores greater than 50 on satisfaction survey. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lens Wear Experience Subject will wear contact lenses for about a month during the day.
Daily disposable multifocal soft contact lens: Daily disposable multifocal soft contact lens that will be worn for 1 month. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Lens Wear Experience |
|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 6.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 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 | 23 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 2 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
Quality of Life Survey
Assessment of the participant's quality of life with the daily disposable multifocal contact lenses; percentage of participants with VAS scores greater than 50 on satisfaction survey.
Time frame: 1 month
Population: Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lens Wear Experience | Quality of Life Survey | 22 Participants |
Primary
Visual Analog Scale
Visual Analog Scale survey of lens wear symptoms (vision) with contact lenses; percentage of participants with positive scores (\> 50).
Time frame: 1 month
Population: Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lens Wear Experience | Visual Analog Scale | 22 Participants |