Myopia
Conditions
Brief summary
The initial subjecting handling experience of neophyte contact lens wearers with Precision1 will be compared to that with a daily disposable lens which mas been on the market for numerous years (1-Day ACUVUE Moist).
Interventions
DEVICEVerafilcon A
Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
DEVICEEtafilcon A
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
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants and Investigators will be masked to which lens type (brand) the participants will be wearing in each eye during the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Is between 18 and 40 years of age inclusively 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 neophyte who has no history of any previous contact lens handling experience; 5. Has a refraction cyl ≤1.00DC in either eye (after vertexing to corneal plane); 6. Has visual acuity ≤0.20 logMAR each eye with study lenses; 7. Demonstrates acceptable fit with study lenses; 8. Demonstrates the ability to successfully insert and remove the study lenses 3 times for each eye (contralateral CL handling, so that each lens type inserted and removed 3x on same eye); 9. Is willing to wear study CLs at least 5 days per week and 6 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 (by self-report); 7. Is aphakic; 8. Has undergone refractive error surgery; 9. Has taken part in another clinical research study within the last 14 days; 10. Any ocular and/or systemic conditions or concomitant medication to contraindicate contact lens wear or be expected to interfere with the primary outcome variables. * 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 Ratings of Lens Handling for Insertion Per Intervention | Baseline | At the initial visit, once participants had successfully completed contact lens insertion and removal training, participants were asked to rate the subjective handling of the lens for insertion on a scale from 0 (worst) to 100 (best) using a visual analog scale per intervention. Higher scores indicate that the lens was very easy to insert. |
| Subjective Ratings of Lens Handling for Removal Per Intervention | Baseline | At the initial visit, once participants had successfully completed contact lens insertion and removal training, participants were asked to rate the subjective handling of the lens for removal on a scale from 0 (worst) to 100 (best) using a visual analog scale per intervention. Higher scores indicate that the lens was very easy to remove. |
Countries
Canada
Participant flow
Recruitment details
Participants were recruited at a single site between December 2019 and May 2022. The first participant was enrolled on December 13, 2019 and the last participant was enrolled on May 20, 2022.
Pre-assignment details
Of 40 enrolled participants, 36 met inclusion criteria and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Verofilcon A / Etafilcon A The participant will wear Verofilcon A in their right eye and Etafilcon A in their left eye.
Verafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Etafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia) | 18 |
| Etafilcon A / Verofilcon A The participant will wear Etafilcon A in their right eye and Verafilcon A in their left eye.
Verafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Etafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia) | 18 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | University closure due to COVID-19 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Etafilcon A / Verofilcon A | Total | Verofilcon A / Etafilcon A |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 36 Participants | 18 Participants |
| Age, Continuous | 23.7 Years STANDARD_DEVIATION 4 | 23.0 Years STANDARD_DEVIATION 3.7 | 22.3 Years STANDARD_DEVIATION 3.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Canada | 18 participants | 36 participants | 18 participants |
| Sex: Female, Male Female | 12 Participants | 22 Participants | 10 Participants |
| Sex: Female, Male Male | 6 Participants | 14 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 36 | 0 / 36 |
| other Total, other adverse events | 0 / 36 | 1 / 36 | 1 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 | 0 / 36 |
Outcome results
Primary
Subjective Ratings of Lens Handling for Insertion Per Intervention
At the initial visit, once participants had successfully completed contact lens insertion and removal training, participants were asked to rate the subjective handling of the lens for insertion on a scale from 0 (worst) to 100 (best) using a visual analog scale per intervention. Higher scores indicate that the lens was very easy to insert.
Time frame: Baseline
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Verofilcon A / Etafilcon A | Subjective Ratings of Lens Handling for Insertion Per Intervention | verofilcon A | 85 score on a scale |
| Verofilcon A / Etafilcon A | Subjective Ratings of Lens Handling for Insertion Per Intervention | etafilcon A | 75 score on a scale |
| Etafilcon A / Verofilcon A | Subjective Ratings of Lens Handling for Insertion Per Intervention | verofilcon A | 80 score on a scale |
| Etafilcon A / Verofilcon A | Subjective Ratings of Lens Handling for Insertion Per Intervention | etafilcon A | 85 score on a scale |
Comparison: Comparison of etafilcon Ap-value: 0.331Wilcoxon (Mann-Whitney)
Comparison: Comparison of verofilcon Ap-value: 0.122Wilcoxon (Mann-Whitney)
Primary
Subjective Ratings of Lens Handling for Removal Per Intervention
At the initial visit, once participants had successfully completed contact lens insertion and removal training, participants were asked to rate the subjective handling of the lens for removal on a scale from 0 (worst) to 100 (best) using a visual analog scale per intervention. Higher scores indicate that the lens was very easy to remove.
Time frame: Baseline
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Verofilcon A / Etafilcon A | Subjective Ratings of Lens Handling for Removal Per Intervention | etaflicon A | 80 score on a scale |
| Verofilcon A / Etafilcon A | Subjective Ratings of Lens Handling for Removal Per Intervention | verofilcon A | 70 score on a scale |
| Etafilcon A / Verofilcon A | Subjective Ratings of Lens Handling for Removal Per Intervention | verofilcon A | 72.50 score on a scale |
| Etafilcon A / Verofilcon A | Subjective Ratings of Lens Handling for Removal Per Intervention | etaflicon A | 90 score on a scale |
Comparison: Comparison of etafilcon Ap-value: 0.13Wilcoxon (Mann-Whitney)
Comparison: Comparison of verofilcon Ap-value: 0.924Wilcoxon (Mann-Whitney)