Presbyopia
Conditions
Brief summary
The objective of the study was to adapt existing multifocal soft lens wearers to a Control Lens for at least 2 weeks and then evaluate the success of switching them to the Test Lens, with a review after 2 weeks.
Detailed description
This prospective, bilateral eye, open label, non-randomized study compared the performance of 2 different designs of daily disposable multifocal contact lenses.
Interventions
DEVICEControl Lens
Daily disposable multifocal soft lens with 2 add design (2ADD) for 2 weeks
DEVICETest Lens
Daily disposable multifocal soft lens with 3 add design (3ADD) for 2 weeks
Sponsors
Centre for Ocular Research & Education, Canada
CooperVision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
42 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A person was eligible for inclusion in the study if he/she: 1. Was 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. Was willing and able to follow instructions and maintain the appointment schedule; 6. Habitually wore multifocal soft contact lenses, for the past 3 months minimum (NOTE: the habitual contact lens type was restricted such that no more than one third were to be the clariti 1 day multifocal and no more than one third were to be MyDay multifocal (this included their equivalent private label brand name); 7. Had refractive astigmatism no higher than -0.75DC in each eye; 8. Was presbyopic and required a reading addition of at least +0.75D and no more than +2.50D in each eye; 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)
Exclusion criteria
A person was excluded from the study if he/she: 1. Was 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. Was 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 |
|---|---|---|
| Comfort Just After Lens Insertion | 2 weeks | Subjective rating measured on a scale of 0-10, 0.5 steps, where 0=Painful, 10=Can't feel the lenses. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Includes all study participants | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Continuous | 52.9 years STANDARD_DEVIATION 6.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 50 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 1 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Comfort Just After Lens Insertion
Subjective rating measured on a scale of 0-10, 0.5 steps, where 0=Painful, 10=Can't feel the lenses.
Time frame: 2 weeks
Population: All participants wore Control Lens and Test Lens in sequential order.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Lens (2ADD) | Comfort Just After Lens Insertion | 9.1 score on a scale | Standard Deviation 1.4 |
| Test Lens (3ADD) | Comfort Just After Lens Insertion | 9.2 score on a scale | Standard Deviation 1.1 |