Astigmatism, Presbyopia
Conditions
Brief summary
The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism.
Detailed description
The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism. This is a prospective, randomized, participant masked, crossover, bilateral dispensing study.
Interventions
DEVICEcomfilcon A
Subjects will be randomized to wear comfilcon A for one month.
DEVICESamfilcon A
Subjects will be randomized to wear samfilcon A for one month.
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
17 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 soft contact lens for the past 3 months minimum; 7. Has refractive astigmatism of at least -0.75DC; 8. Is presbyopic and requires a reading addition of at least +0.75D; 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; cylinder -0.75 to -1.75DC; near addition +0.75 to +2.50).
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; 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 and/or the care product Opti-Free PureMoist being 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. \* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Lens Handling at Insertion | Day 28 | Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy). |
Countries
Canada, United States
Participant flow
Pre-assignment details
Of the 64 eligible participants, 63 were dispensed with study products, and one participant withdrew after the screening visit due to lens handling and general time commitment concerns.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study. The baseline measures include information of all 64 eligible participants.
Of the 64 eligible participants, 63 were dispensed with study products, and one participant withdrew after the screening visit due to lens handling and general time commitment concerns. | 64 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Withdrawal by Subject | 0 | 2 |
| Second Intervention | Adverse Event | 1 | 1 |
| Second Intervention | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 64 Participants | — |
| Age, Continuous | 53.9 years STANDARD_DEVIATION 8.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 48 participants | — |
| Region of Enrollment United States | 16 participants | — |
| Sex: Female, Male Female | 47 Participants | — |
| Sex: Female, Male Male | 17 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 63 |
| other Total, other adverse events | 9 / 61 | 9 / 63 |
| serious Total, serious adverse events | 0 / 61 | 0 / 63 |
Outcome results
Primary
Ease of Lens Handling at Insertion
Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy).
Time frame: Day 28
Population: Out of 58 subjects who completed the study, data of three participants from the comfilcon A Arm /group and data of two participants from samfilcon A Arm / group was excluded from the analysis due to minor protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Ease of Lens Handling at Insertion | 8.6 score on a scale | Standard Deviation 1.6 |
| Samfilcon A | Ease of Lens Handling at Insertion | 8.8 score on a scale | Standard Deviation 1.8 |