Astigmatism
Conditions
Brief summary
The objective of the study was to compare the clinical performance of two monthly toric silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each.
Detailed description
This study was a prospective, bilateral eye, subjected-masked, randomized, 1-month cross-over, daily-wear design involving two different silicone hydrogel toric lens types. Each lens type will be worn bilaterally for approximately one month.
Interventions
DEVICELens A (comfilcon A toric lens)
One month wear
DEVICELens B (lehfilcon A toric lens)
One month wear
Sponsors
Centre for Ocular Research & Education, Canada
CooperVision International Limited (CVIL)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
1. Is between 18 and 39 years of age (inclusive) 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, 6 days a week; 5. Is willing and able to follow instructions and maintain the appointment schedule; 6. Habitually wears of toric soft contact lenses binocularly. 1. No more than 1/3 of the participants should be wearing daily disposable soft toric lenses; 2. the remaining 2/3+ of the participants must be planned frequent replacement soft toric lens wearers as follows: * i. TOTAL30 for Astigmatism: maximum of 3 (∼10%) (no target percentage) * ii. Biofinity toric: maximum of 13 (∼40%) (PLUS a target of minimum 10 (∼30%)) * iii. Air Optix for Astigmatism (inclusive of +Hydraglyde): maximum of 10 (∼30%) (PLUS a target of minimum 7 (∼20%)) * iv. ULTRA for Astigmatism: maximum of 5 (∼15%) (no target percentage) * v. Acuvue Vita for Astigmatism: maximum of 3 (∼10%) (no target percentage) * vi. Acuvue Oasys for Astigmatism: maximum of 10 (∼30%) (no target percentage) * vii. Other brands of frequent replacement: maximum of 7 (∼20%) (no target percentage) 7. Has refractive astigmatism of at least -0.75DC but no more than -2.75DC in each eye that is correctable with a soft toric lens with a cylinder power of no greater than -2.25DC; 8. Is ammetropic and requires a spectacle spherical component of +8.00 to -10.00D inclusively; 9. Can be fit and achieve binocular distance vision of at least 20/32 Snellen with the available lens parameters
Exclusion criteria
1. Is participating in any concurrent clinical or research study; 2. Has any known active ocular disease and/or infection that contraindicates contact lens wear; 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 contact lens wear or a study outcome variable; 5. Has known sensitivity to the diagnostic sodium fluorescein used in the study; 6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; 7. Has undergone refractive error surgery or intraocular surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Handling on Removal | At the end of one month of wear | Lens Handling on Removal, using a 0-100 scale (0= very difficult, 100=very easy). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distance Visual Acuity | At the end of one month of wear | Distance Visual Acuity, using Snellen converted to logMAR. |
Countries
Canada, United States
Participant flow
Pre-assignment details
There were 50 participants enrolled and 1 was discontinued due to lost to follow-up prior to the first lens dispense.
Participants by arm
| Arm | Count |
|---|---|
| Analysis Population All participants who completed study. (Total Study Population n=49) | 49 |
| Total | 49 |
Baseline characteristics
| Characteristic | Analysis Population | — |
|---|---|---|
| Age, Continuous | 30.4 years STANDARD_DEVIATION 5.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 31 Participants | — |
| Sex: Female, Male Male | 18 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 49 |
| other Total, other adverse events | 5 / 49 | 4 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 |
Outcome results
Primary
Lens Handling on Removal
Lens Handling on Removal, using a 0-100 scale (0= very difficult, 100=very easy).
Time frame: At the end of one month of wear
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens A | Lens Handling on Removal | 89 units on a scale | Standard Deviation 17 |
| Lens B | Lens Handling on Removal | 91 units on a scale | Standard Deviation 14 |
Secondary
Distance Visual Acuity
Distance Visual Acuity, using Snellen converted to logMAR.
Time frame: At the end of one month of wear
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens A | Distance Visual Acuity | -0.06 logMAR | Standard Deviation 0.06 |
| Lens B | Distance Visual Acuity | -0.06 logMAR | Standard Deviation 0.06 |