Presbyopia
Conditions
Brief summary
The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B.
Detailed description
The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B. This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study conducted at up to 5 clinical practice sites in the United States. Subjects were dispensed their habitual lenses for two weeks prior to randomization of Test Lens and Control Lens. Each lens type will be worn for 2 weeks after randomization.
Interventions
Sponsors
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
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 (sphere +4 to -6; near addition or LOW, MEDIUM, HIGH).
Exclusion criteria
1. Is participating in any concurrent clinical or research study; 2. Habitually wears one of the study contact lenses; 3. Has any known active\* ocular disease and/or infection that contraindicates contact lens wear; 4. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 5. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable; 6. Has known sensitivity to the diagnostic sodium fluorescein used in the study; 7. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; 8. Has undergone refractive error surgery or intraocular surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective At-home Ratings for Ease of Lens Handling for Insertion | Day 13 | Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy) |
Countries
United States
Participant flow
Recruitment details
60 subjects were enrolled and 1 subject discontinued because of screen failure prior to dispense of their habitual lenses.
Pre-assignment details
All 59 subjects wore their habitual lenses for two weeks prior to randomization to test lens and control lens.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Subjects wore their habitual lenses for two weeks and then randomized to wear Test lens A and Control Lens B for 2 weeks. | 59 |
| Total | 59 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 3 Participants | — |
| Age, Categorical Between 18 and 65 years | 56 Participants | — |
| Age, Continuous | 54.5 years STANDARD_DEVIATION 7.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 59 participants | — |
| Sex: Female, Male Female | 50 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 59 | 0 / 59 |
| other Total, other adverse events | 0 / 59 | 0 / 59 | 0 / 59 |
| serious Total, serious adverse events | 0 / 59 | 0 / 59 | 0 / 59 |
Outcome results
Primary
Subjective At-home Ratings for Ease of Lens Handling for Insertion
Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy)
Time frame: Day 13
Population: One subject was not included in the analysis for all study arms because of protocol deviation. One more subject was excluded form the analysis from Len B control Arm only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Habitual Lenses | Subjective At-home Ratings for Ease of Lens Handling for Insertion | 8.90 units on a scale | Standard Deviation 1.59 |
| Lens A (Test) | Subjective At-home Ratings for Ease of Lens Handling for Insertion | 8.28 units on a scale | Standard Deviation 2.1 |
| Lens B (Control) | Subjective At-home Ratings for Ease of Lens Handling for Insertion | 9.18 units on a scale | Standard Deviation 1.12 |