Presbyopia
Conditions
Brief summary
The objective of the study was to compare the lens performance of two daily disposable multifocal contact lenses.
Detailed description
This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type was worn for approximately 3-4 weeks: the lens prescription of each lens type was optimized after a 3-8 days wearing experience, then participants began a 2 week (14-21 day) wear period.
Interventions
Daily Disposable Multifocal Contact Lens for 2 weeks
DEVICETest Lens (senofilcon A)
Daily Disposable Multifocal Contact Lens for 2 weeks
Sponsors
Centre for Ocular Research & Education, Canada
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
42 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Were at least 42 years of age and had full legal capacity to volunteer; 2. Had read and signed an information consent letter; 3. Self-reported having had a full eye examination in the previous two years; 4. Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week 5. Were willing and able to follow instructions and maintain the appointment schedule; 6. Habitually wore multifocal soft contact lenses, for the past 3 months minimum * Maximum of 7 participants per site were habitual wearers of daily disposable lenses * Maximum of 3 habitual wearers per site of 1-Day Acuvue Moist Multifocal * Maximum of 1 habitual wearer per site of ACUVUE OASYS MAX 1-Day MULTIFOCAL * Maximum of 3 habitual wearers per site of MyDay Multifocal * Maximum of 7 participants per site were habitual wearers of frequent replacement lenses * Maximum of 1 habitual wearer per site of ACUVUE OASYS for PRESBYOPIA 7. Had refractive astigmatism no higher than -0.75DC in each eye; 8. Were presbyopic and required a reading addition of at least +0.75D and no more than +2.50D; 9. Could be fit and achieved binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deemed to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS, near addition as per study design)
Exclusion criteria
A person was excluded from the study if they: 1. Were participating in any concurrent clinical or research study; 2. Had any known active ocular disease and/or infection that contraindicated contact lens wear; 3. Had a systemic condition that in the opinion of the investigator may have affected a study outcome variable; 4. Were using any systemic or topical medications that in the opinion of the investigator may have affected contact lens wear or a study outcome variable; 5. Had known sensitivity to the diagnostic sodium fluorescein to be used in the study; 6. Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment; 7. Had undergone refractive error surgery or interocular surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Handling for Removal | 2 Weeks | Subjective rating for ease of removal of the study lenses on a 0-100 scale, where 0=Very difficult and 100=Very easy. Collected once at the end of 2 weeks of wear. |
Countries
Canada, United States
Participant flow
Pre-assignment details
Of the 60 participants screened, 1 exited the study prior to randomization due to screen failure.
Participants by arm
| Arm | Count |
|---|---|
| Total Study Population All participants that attended one or more study visits | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1: First Intervention, 2 Weeks | Protocol Violation | 0 | 1 |
| Period 1: First Intervention, 2 Weeks | Withdrawal by Subject | 0 | 1 |
| Period 2: Second Intervention, 2 Weeks | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Total Study Population | — |
|---|---|---|
| Age, Continuous | 53.3 years STANDARD_DEVIATION 6.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 47 Participants | — |
| Sex: Female, Male Male | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 58 |
| other Total, other adverse events | 2 / 57 | 3 / 58 |
| serious Total, serious adverse events | 0 / 57 | 0 / 58 |
Outcome results
Primary
Lens Handling for Removal
Subjective rating for ease of removal of the study lenses on a 0-100 scale, where 0=Very difficult and 100=Very easy. Collected once at the end of 2 weeks of wear.
Time frame: 2 Weeks
Population: Participants that completed all study visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Lens | Lens Handling for Removal | 94 score on a scale | Standard Deviation 10 |
| Test Lens | Lens Handling for Removal | 95 score on a scale | Standard Deviation 10 |