Myopia
Conditions
Brief summary
The purpose of this study is to evaluate the performance of DAILIES TOTAL1 daily disposable contact lenses with regards to subjective symptoms (comfort, dryness, vision) in lens wearers who use identify themselves as substantial digital device users (at least eight hours of digital device use per day).
Interventions
Daily disposable silicone hydrogel contact lenses indicated for the optical correction of 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. Are between 18 and 40 years of age (inclusive) and has full legal capacity to volunteer; 2. Have read and signed an information consent letter; 3. Are willing and able to follow instructions and maintain the appointment schedule; 4. Are a digital device user (at least 8 hours on a typical day using any combination of digital devices such as personal computer \[PC\], laptop, smartphone or tablet); 5. Are a habitual wearer of daily wear, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 13+ hours/day on a typical day during the month prior to enrolment; 6. The habitual lens type brand will be restricted such that a maximum of 7 participants will be included in the study for each lens brand/material; 7. Have a vertex corrected spherical equivalent distance refraction within -0.50 Diopter (D) to -9.00D in each eye; 8. Have a vertex corrected refractive cylinder ≤ -0.75 cylindrical correction in each eye after vertexing to the corneal plane; 9. Demonstrate an acceptable fit and achieves best corrected visual acuity of at least 0.10 logMAR in each eye with DAILIES TOTAL1® contact lenses; 10. Are willing to wear DAILIES TOTAL1® contact lenses at least 5 days per week and 13+ hours per day throughout the study.
Exclusion criteria
1. Are participating in any concurrent clinical or research study involving intervention or invasive ocular tests; 2. Are presbyopic or habitually use a reading addition for close work; 3. Have any known active\* ocular disease and/or infection; \[\* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and mild dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.\] 4. Meet the diagnosis of dry eye disease as per the following combination: 1. Meets the symptom criteria of Contact Lens Dry Eye Questionnaire (CLDEQ-8) score ≥12 2. And they show 1 of the following 2 signs: * Either sodium fluorescein (NaFl) staining (either \[cornea \>5 dots\] or \[conjunctiva \>9 dots\] or \[lid margin \>2mm length AND ≥25% width\]); * Or non-invasive tear film break-up time (NITBUT) (no contact lens) \<10 seconds. 5. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;+ \[+ Any potential exclusion will be reviewed with the Lead Investigator or Principal Investigator prior to final decision making.\] 6. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 7. Are a current wearer of DAILIES TOTAL1® daily disposable contact lenses; 8. Have known sensitivity to the diagnostic pharmaceutical sodium fluorescein to be used in the study; 9. Have undergone refractive error surgery; 10. Are a member of the Centre for Ocular Research & Education (CORE) directly involved in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Rating of Comfort After 8 Hours or More of Digital Device Use | Day 14+2 | Participants rate their overall comfort after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best). |
| Subjective Rating of Dryness After 8 Hours or More of Digital Device Use | Day 14+2 | Participants rate their overall dryness after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best). |
| Subjective Rating of Clarity of Vision After 8 Hours or More of Digital Device Use | Day 14+2 | Participants rate their overall clarity of vision after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best). |
Countries
Canada
Participant flow
Recruitment details
Participants were recruited at a single site between March 2024 and October 2024. The first participant was enrolled on March 18, 2024 and the last participant was enrolled on October 9, 2024.
Pre-assignment details
Out of the 41 participants that were enrolled, 35 met the inclusion critieria, and 35 were dispensed with the study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Refit Refit and dispense participant with delefilcon A contact lenses and evaluate lens performance
Delefilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of myopia and hyperopia | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Refit | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 35 Participants | — |
| Age, Continuous | 25.5 years STANDARD_DEVIATION 6.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 35 participants | — |
| Sex: Female, Male Female | 29 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
Subjective Rating of Clarity of Vision After 8 Hours or More of Digital Device Use
Participants rate their overall clarity of vision after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best).
Time frame: Day 14+2
Population: 3 people discontinued before the study could be completed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Rating of Clarity of Vision After 8 Hours or More of Digital Device Use | 95 score on a scale |
Primary
Subjective Rating of Comfort After 8 Hours or More of Digital Device Use
Participants rate their overall comfort after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best).
Time frame: Day 14+2
Population: 3 people discontinued before the study could be completed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Rating of Comfort After 8 Hours or More of Digital Device Use | 96 score on a scale |
Primary
Subjective Rating of Dryness After 8 Hours or More of Digital Device Use
Participants rate their overall dryness after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best).
Time frame: Day 14+2
Population: 3 people discontinued before the study could be completed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refit | Subjective Rating of Dryness After 8 Hours or More of Digital Device Use | 93 score on a scale |