Presbyopia
Conditions
Brief summary
The aim of this study is to evaluate the patient subjective experiences of the monthly multifocal lens when compared to the daily disposable multifocal lens after 15 minutes of daily wear.
Detailed description
This is a single-blind, interventional, prospective, direct refit, bilateral wear study.
Interventions
Sponsors
CooperVision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
All participants received Lens A and then Lens B in fixed-sequence order.
Eligibility
Sex/Gender
ALL
Age
42 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Is at least 42 years of age and has full legal capacity to volunteer. * Has read and signed an information consent letter. * Self-reports having a full eye examination in the previous two years. * Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week. * Is willing and able to follow instructions and maintain the appointment schedule. * Habitually wears multifocal soft contact lenses, or sphere lenses for monovision, or sphere lenses for monovision, or sphere lenses for distance vision correction and use spectacles for near vision correction, for the past 3 months minimum. * Has refractive astigmatism no higher than -0.75DC. * Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D. * 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
* Is participating in any concurrent clinical or research study. * Has any known active ocular disease and/or infection that contraindicates contact lens wear. * Has a systemic condition that in the opinion of the investigator may affect a study outcome variable. * Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable. * Has known sensitivity to the diagnostic sodium fluorescein used in the study. * Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment. * Has undergone refractive error surgery or intraocular surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Comfort Ratings on Insertion | At insertion | Subjective comfort ratings on insertion were measured on a scale from 0 - 10, where 0= extremely uncomfortable and 10= can't feel. |
Countries
Mexico
Participant flow
Pre-assignment details
Forty-two participants were screened. All participants wore Lens A first for 15 minutes and then wore Lens B for 15 minutes. All the participants who were in the study were included in the analysis. (n=42)
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Includes all study participants. | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Categorical Lens A <=18 years | 0 Participants | — |
| Age, Categorical Lens A >=65 years | 0 Participants | — |
| Age, Categorical Lens A Between 18 and 65 years | 42 Participants | — |
| Age, Categorical Lens B <=18 years | 0 Participants | — |
| Age, Categorical Lens B >=65 years | 0 Participants | — |
| Age, Categorical Lens B Between 18 and 65 years | 42 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 31 Participants | — |
| Sex: Female, Male Male | 11 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 |
| other Total, other adverse events | 0 / 42 | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
Primary
Subjective Comfort Ratings on Insertion
Subjective comfort ratings on insertion were measured on a scale from 0 - 10, where 0= extremely uncomfortable and 10= can't feel.
Time frame: At insertion
Population: \[Not Specified\]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens A | Subjective Comfort Ratings on Insertion | 9.19 Units on scale | Standard Deviation 0.86 |
| Lens B | Subjective Comfort Ratings on Insertion | 9.47 Units on scale | Standard Deviation 0.67 |