Presbyopia
Conditions
Brief summary
The objective of the study was to adapt existing multifocal soft lens wearers to a CONTROL lens for 2 weeks and then evaluate the success of switching them to the TEST lens, with a review after 2 weeks.
Detailed description
This was a prospective, crossover, bilateral daily wear, and subject masked dispensing study. The habitual contact lenses were not optimized. There was no randomization of the study lenses, participants wore the control lenses for the first wear period and the test for the second wear period. Participants wore each study lens for 3-7 days and then attend a prescription optimization visit. After this optimization visit, they wore each study lens for a 2-week period. During the 2-week wear period, participants recorded their subjective lens-wear experience remotely.
Interventions
DEVICEControl lenses
Control Multifocal lenses
DEVICETest lenses
Test Multifocal lenses
Sponsors
CooperVision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
42 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Is at least 42 years of age and has full legal capacity to volunteer; 2. Has read and signed an information consent letter; 3. Self reports having a full eye examination in the previous two years; 4. Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week; 5. Is willing and able to follow instructions and maintain the appointment schedule; 6. Habitually wears multifocal soft contact lenses, for the past 3 months minimum; 7. Has refractive astigmatism no higher than -0.75DC; 8. Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D; 9. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS)
Exclusion criteria
1. Is participating in any concurrent clinical or research study; 2. Has any known active\* ocular disease and/or infection that contraindicates contact lens wear; 3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable; 5. Has known sensitivity to the diagnostic sodium fluorescein used in the study; 6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; 7. Has undergone refractive error surgery or intraocular surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort on Insertion | Day 1 after Lens Dispense Visit | Subjective ratings of comfort on insertion using a 0-10 scale, in 0.5 steps (0=- painful, 10- Can't feel the lenses). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study All subjects wore control lenses for two weeks and then test lenses for two weeks. | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Control Lens | Physician Decision | 4 |
| Test Lens | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 63 Participants | — |
| Age, Continuous | 53.9 years STANDARD_DEVIATION 6.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 63 participants | — |
| Sex: Female, Male Female | 51 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 63 |
| other Total, other adverse events | 2 / 63 | 2 / 63 |
| serious Total, serious adverse events | 0 / 63 | 0 / 63 |
Outcome results
Primary
Comfort on Insertion
Subjective ratings of comfort on insertion using a 0-10 scale, in 0.5 steps (0=- painful, 10- Can't feel the lenses).
Time frame: Day 1 after Lens Dispense Visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Lens | Comfort on Insertion | 9.2 units on a scale | Standard Deviation 1.1 |
| Test Lens | Comfort on Insertion | 9.2 units on a scale | Standard Deviation 1 |