Myopia
Conditions
Brief summary
The purpose of this study is to evaluate the performance of Precision1 DD CLs with regard to subjective symptoms (dryness, comfort, vision), lens fit and time to haze in CL wearers who identify themselves as heavy digital devices users (at least 6 hours of digital device use per day).
Interventions
Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Sponsors
Alcon Research
University of Waterloo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Is between 18 and 40 years of age (inclusive) and has full legal capacity to volunteer; 2. Has read and signed an information consent letter; 3. Is willing and able to follow instructions and maintain the appointment schedule; 4. Is a heavy digital device user (at least 6 hours on a typical day using any combination of digital devices such as PC, laptop, smartphone, or tablet); 5. Is a habitual wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision, not a current wearer of Precision1 lenses) for at least 5 days/week and at least 10 hours/day during the month prior to enrollment; 6. Has a vertex corrected spherical equivalent distance refraction that ranges between -0.50D to -6.00D in each eye; 7. Has a vertex corrected refractive cylinder of no more than -1.00D cylindrical correction in each eye after vertexing to the corneal plane; 8. Demonstrates an acceptable fit and achieves best corrected visual acuity of at least 0.20 log MAR in each eye with Precision1 contact lenses; 9. Is willing to wear Precision1 CLs at least 5 days per week and 10 hours per day throughout the study;
Exclusion criteria
1. Is participating in any concurrent clinical or research study; 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 the diagnostic pharmaceuticals to be used in the study; 6. Is pregnant, lactating or planning a pregnancy at the time of enrolment; 7. Is aphakic; 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 |
|---|---|---|
| Subjective Comfort After Contact Lens Insertion | Dispense Visit (Day 0) | Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best). |
| Subjective Dryness After Contact Lens Insertion | Dispense Visit (Day 0) | Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best). |
| Subjective Rating of Clarity of Vision After Contact Lens Insertion | Dispense Visit (Day 0) | Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best). |
| Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use | Day 1 | Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best). |
| Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use | Day 1 | Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best). |
| Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use | Day 1 | Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best). |
| Subjective Comfort at End of Day With Contact Lens Wear | Day 1 | Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best). |
| Subjective Dryness at End of Day With Contact Lens Wear | Day 1 | Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best). |
| Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear | Day 1 | Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best). |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Refit Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance.
Verofilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia) | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Refit | — |
|---|---|---|
| Age, Continuous | 25.8 years STANDARD_DEVIATION 6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 32 participants | — |
| Sex: Female, Male Female | 27 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 1 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
Primary
Subjective Comfort After Contact Lens Insertion
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Time frame: Day 7
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Comfort After Contact Lens Insertion | 98 score on a scale |
Primary
Subjective Comfort After Contact Lens Insertion
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Time frame: Day 1
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Refit | Subjective Comfort After Contact Lens Insertion | 96 score on a scale |
Primary
Subjective Comfort After Contact Lens Insertion
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Time frame: Dispense Visit (Day 0)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Comfort After Contact Lens Insertion | 95 score on a scale |
Primary
Subjective Comfort After Contact Lens Insertion
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Time frame: Day 10
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Comfort After Contact Lens Insertion | 95 score on a scale |
Primary
Subjective Comfort After Contact Lens Insertion
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Time frame: Followup visit (occurring at a single visit any day from Day 12-16)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Comfort After Contact Lens Insertion | 90 score on a scale |
Primary
Subjective Comfort at End of Day With Contact Lens Wear
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Time frame: Day 10
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Comfort at End of Day With Contact Lens Wear | 89 score on a scale |
Primary
Subjective Comfort at End of Day With Contact Lens Wear
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Comfort at End of Day With Contact Lens Wear | 100 score on a scale |
Primary
Subjective Comfort at End of Day With Contact Lens Wear
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Time frame: Day 7
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Comfort at End of Day With Contact Lens Wear | 90 score on a scale |
Primary
Subjective Comfort at End of Day With Contact Lens Wear
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Time frame: Followup visit (occurring at a single visit any day from Day 12-16)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Comfort at End of Day With Contact Lens Wear | 90 score on a scale |
Primary
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Time frame: Day 7
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use | 90 score on a scale |
Primary
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Time frame: Day 10
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use | 90 score on a scale |
Primary
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use | 99 score on a scale |
Primary
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Time frame: Followup visit (occurring at a single visit any day from Day 12-16)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use | 90 score on a scale |
Primary
Subjective Dryness After Contact Lens Insertion
Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).
Time frame: Day 10
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Dryness After Contact Lens Insertion | 90 score on a scale |
Primary
Subjective Dryness After Contact Lens Insertion
Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).
Time frame: Dispense Visit (Day 0)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Dryness After Contact Lens Insertion | 100 score on a scale |
Primary
Subjective Dryness After Contact Lens Insertion
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Time frame: Followup visit (occurring at a single visit any day from Day 12-16)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Dryness After Contact Lens Insertion | 90 score on a scale |
Primary
Subjective Dryness After Contact Lens Insertion
Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Dryness After Contact Lens Insertion | 100 score on a scale |
Primary
Subjective Dryness After Contact Lens Insertion
Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).
Time frame: Day 7
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Dryness After Contact Lens Insertion | 100 score on a scale |
Primary
Subjective Dryness at End of Day With Contact Lens Wear
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Time frame: Day 7
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Dryness at End of Day With Contact Lens Wear | 90 score on a scale |
Primary
Subjective Dryness at End of Day With Contact Lens Wear
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Time frame: Followup visit (occurring at a single visit any day from Day 12-16)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Dryness at End of Day With Contact Lens Wear | 88 score on a scale |
Primary
Subjective Dryness at End of Day With Contact Lens Wear
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Dryness at End of Day With Contact Lens Wear | 100 score on a scale |
Primary
Subjective Dryness at End of Day With Contact Lens Wear
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Time frame: Day 10
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Dryness at End of Day With Contact Lens Wear | 85 score on a scale |
Primary
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Time frame: Followup visit (occurring at a single visit any day from Day 12-16)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use | 90 score on a scale |
Primary
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Time frame: Day 10
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use | 90 score on a scale |
Primary
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use | 100 score on a scale |
Primary
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Time frame: Day 7
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use | 90 score on a scale |
Primary
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).
Time frame: Day 10
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Rating of Clarity of Vision After Contact Lens Insertion | 95 score on a scale |
Primary
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).
Time frame: Dispense Visit (Day 0)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Rating of Clarity of Vision After Contact Lens Insertion | 98 score on a scale |
Primary
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Rating of Clarity of Vision After Contact Lens Insertion | 99 score on a scale |
Primary
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).
Time frame: Day 7
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Rating of Clarity of Vision After Contact Lens Insertion | 100 score on a scale |
Primary
Subjective Rating of Clarity of Vision After Contact Lens Insertion
Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).
Time frame: Followup visit (occurring at a single visit any day from Day 12-16)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Rating of Clarity of Vision After Contact Lens Insertion | 91 score on a scale |
Primary
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
Participants rate their end of day rating of vision clarity on a scale from 0 (worst) to 100 (best).
Time frame: Followup visit (occurring at a single visit any day from Day 12-16)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear | 90 score on a scale |
Primary
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
Participants rate their end of day rating of vision clarity on a scale from 0 (worst) to 100 (best).
Time frame: Day 7
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear | 95 score on a scale |
Primary
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best).
Time frame: Day 10
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear | 90 score on a scale |
Primary
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear
Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best).
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear | 100 score on a scale |
Primary
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Time frame: Day 7
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use | 95 score on a scale |
Primary
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Time frame: Day 10
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use | 95 score on a scale |
Primary
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Time frame: Followup visit (occurring at a single visit any day from Day 12-16)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use | 90 score on a scale |
Primary
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use
Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use | 100 score on a scale |