Presbyopia
Conditions
Brief summary
To evaluate and compare the performance of two monthly replacement multifocal contact lenses in existing wearers.
Detailed description
This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type was worn for approximately 4-6 weeks: the lens prescription of each lens type was optimized after 3-10 days wearing experience, prior to starting a 1-month (28-32 days) wear period.
Interventions
DEVICEControl Lens (comfilcon A)
Multifocal monthly replacement contact lens for 1 month
DEVICETest Lens (lehfilcon A)
Multifocal monthly replacement contact lens for 1 month
Sponsors
Centre for Ocular Research & Education, Canada
CooperVision International Limited (CVIL)
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 spherical multifocal soft contact lenses, for the past 3 months minimum: * Maximum of 4 participants (out of 12) per site could be habitual wearers of daily disposable lenses, * Maximum of 4 participants (out of 12) per site could be habitual wearers of Biofinity Multifocal, * Maximum of 4 participants (out of 12) per site could be habitual wearers of either TOTAL30 Multifocal or AirOptix plus HydraGlyde Multifocal 7. Had 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. Could be fit and achieve binocular distance vision of at least 20/30 Snellen which participants also deem to be 'acceptable', with the available study lens parameters (Distance sphere +4 to -6; near addition as per study design).
Exclusion criteria
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 or ocular 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 affect contact lens wear or a study outcome variable; 5. Had known sensitivity to the diagnostic sodium fluorescein 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 intraocular surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Handling for Insertion | 1 month | Subjective rating collected in office using a 0-100 scale, where 0=Very difficult and 100=Very easy. The participant rated the study lens considering a typical day in the last 1 month of wear. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Participants who completed all study visits. | 59 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2: Second Intervention | Unable to attend study visit | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Continuous | 53.2 years STANDARD_DEVIATION 6.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 40 Participants | — |
| Sex: Female, Male Male | 19 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 59 |
| other Total, other adverse events | 4 / 60 | 4 / 59 |
| serious Total, serious adverse events | 0 / 60 | 0 / 59 |
Outcome results
Primary
Lens Handling for Insertion
Subjective rating collected in office using a 0-100 scale, where 0=Very difficult and 100=Very easy. The participant rated the study lens considering a typical day in the last 1 month of wear.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Lens | Lens Handling for Insertion | 95 score on a scale | Standard Deviation 9 |
| Test Lens | Lens Handling for Insertion | 96 score on a scale | Standard Deviation 8 |