Astigmatism
Conditions
Brief summary
Bilateral dispensing study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric lenses
Detailed description
Prospective, double-masked (investigator and participant), bilateral, randomized, cross-over dispensing study comparing the MyDay Toric (test) against the 1-day Acuvue Moist for Astigmatism (control), and Dailies Aquacomfort Plus Toric (control) lenses
Interventions
DEVICEDailies Aquacomfort Plus Toric
daily disposable contact lens
DEVICE1-Day Acuvue Moist for Astigmatism
daily disposable contact lens
DEVICEMyDay Toric
daily disposable contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Is at least 17 years of age and has full legal capacity to volunteer; 2. Has had a self-reported oculo-visual examination in the last two years. 3. Has read and signed an information consent letter; 4. Is willing and able to follow instructions and maintain the appointment schedule; 5. Is an adapted soft contact lens wearer; 6. Is willing to wear contact lens in both eyes for the duration of the study; 7. Has a minimum spectacle astigmatism of - 0.75; 8. Can be fit with the three study contact lens types in the powers available; 9. Has a visual acuity of 20/30 or better in each eye with habitual correction, or 20/20 best corrected vision (for binocular distance acuity); 10. Can achieve a distance visual acuity of 20/30 (0.18 logMar) or better in each eye with the study contact lenses. 11. Has clear corneas and no active\* ocular disease; * 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.
Exclusion criteria
1. Is participating in any concurrent clinical trial; 2. Has any known active\* ocular disease and/or infection; 3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 5. Has known sensitivity to fluorescein dye or products to be used in the study; 6. Appears to have any active\* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses; 7. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit); 8. Is aphakic; 9. Has undergone refractive error surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort | 1 week | Subjective ratings of lens performance for comfort assessed. Comfort Scale 0-10, 0=painful, 10=can't feel the lenses. |
| Dryness | 1 week | Subjective ratings of lens performance for dryness assessed. Dryness Scale 0-10, 0=extremely dry, 10=no dryness |
| Visual Quality | 1 week | Subjective ratings of lens performance for visual quality assessed. Visual quality Scale 0-10, 0=completely dissatisfied, 10=completely satisfied |
| Lens Preference With Respect to Overall Comfort | 1 week | Overall comfort preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference |
| Lens Preference With Respect to Visual Quality | 1 week | Overall visual quality preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference |
Countries
Canada
Participant flow
Pre-assignment details
60 subjects were enrolled for this study (assigned a subjectID), but 11 of these subjects were screen failures, leaving 49 subjects who were randomized for lens assignments.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants A bilateral dispensing of MyDay Toric, 1-Day Acuvue Moist for Astigmatism, and Dailies Aqua Comfort Plus Toric Contact Lenses | 49 |
| Total | 49 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 49 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 49 Participants | — |
| Sex: Female, Male Female | 37 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 49 | 0 / 49 |
| other Total, other adverse events | 0 / 49 | 0 / 49 | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 | 0 / 49 |
Outcome results
Primary
Comfort
Subjective ratings of lens performance for comfort assessed. Comfort Scale 0-10, 0=painful, 10=can't feel the lenses.
Time frame: 1 week
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| MyDay Toric Contact Lens | Comfort | 8 units on a scale | Standard Deviation 1.37 |
| 1-Day Acuvue Moist for Astigmatism Contact Lens | Comfort | 9 units on a scale | Standard Deviation 1.14 |
| Dailies Aquacomfort Plus Toric Contact Lens | Comfort | 8 units on a scale | Standard Deviation 2.05 |
Primary
Dryness
Subjective ratings of lens performance for dryness assessed. Dryness Scale 0-10, 0=extremely dry, 10=no dryness
Time frame: 1 week
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| MyDay Toric Contact Lens | Dryness | 9 units on a scale | Standard Deviation 1.69 |
| 1-Day Acuvue Moist for Astigmatism Contact Lens | Dryness | 8 units on a scale | Standard Deviation 1.65 |
| Dailies Aquacomfort Plus Toric Contact Lens | Dryness | 7 units on a scale | Standard Deviation 2.18 |
Primary
Lens Preference With Respect to Overall Comfort
Overall comfort preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference
Time frame: 1 week
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MyDay Toric Contact Lens | Lens Preference With Respect to Overall Comfort | Strongly Prefer MyDay Toric | 15 Participants |
| MyDay Toric Contact Lens | Lens Preference With Respect to Overall Comfort | Slightly Prefer MyDay Toric | 6 Participants |
| MyDay Toric Contact Lens | Lens Preference With Respect to Overall Comfort | Strongly Prefer 1Day Acuvue Moist Toric | 14 Participants |
| MyDay Toric Contact Lens | Lens Preference With Respect to Overall Comfort | Slightly Prefer 1Day Acuvue Moist Toric | 5 Participants |
| MyDay Toric Contact Lens | Lens Preference With Respect to Overall Comfort | Strongly Prefer Dailies Aquacomfort Plus Toric | 5 Participants |
| MyDay Toric Contact Lens | Lens Preference With Respect to Overall Comfort | Slighlty Prefer Dailies Aquacomfort Plus Toric | 3 Participants |
| MyDay Toric Contact Lens | Lens Preference With Respect to Overall Comfort | No Preference | 1 Participants |
Primary
Lens Preference With Respect to Visual Quality
Overall visual quality preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference
Time frame: 1 week
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MyDay Toric Contact Lens | Lens Preference With Respect to Visual Quality | Strongly Prefer MyDay Toric | 10 Participants |
| MyDay Toric Contact Lens | Lens Preference With Respect to Visual Quality | Slightly Prefer MyDay Toric | 4 Participants |
| MyDay Toric Contact Lens | Lens Preference With Respect to Visual Quality | Strongly Prefer 1Day Acuvue Moist Toric | 9 Participants |
| MyDay Toric Contact Lens | Lens Preference With Respect to Visual Quality | Slightly Prefer 1Day Acuvue Moist Toric | 8 Participants |
| MyDay Toric Contact Lens | Lens Preference With Respect to Visual Quality | Strongly Prefer Dailies Aquacomfort Plus Toric | 6 Participants |
| MyDay Toric Contact Lens | Lens Preference With Respect to Visual Quality | Slightly Prefer Dailies Aquacomfort Plus Toric | 2 Participants |
| MyDay Toric Contact Lens | Lens Preference With Respect to Visual Quality | No Preference | 10 Participants |
Primary
Visual Quality
Subjective ratings of lens performance for visual quality assessed. Visual quality Scale 0-10, 0=completely dissatisfied, 10=completely satisfied
Time frame: 1 week
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| MyDay Toric Contact Lens | Visual Quality | 9 units on a scale | Standard Deviation 1.41 |
| 1-Day Acuvue Moist for Astigmatism Contact Lens | Visual Quality | 8 units on a scale | Standard Deviation 1.14 |
| Dailies Aquacomfort Plus Toric Contact Lens | Visual Quality | 8 units on a scale | Standard Deviation 1.81 |