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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refit | Experimental | Refit and dispense participant with delefilcon A contact lenses and evaluate lens performance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A contact lenses | Device | Daily disposable silicone hydrogel contact lenses indicated for the optical correction of myopia and hyperopia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 14+2 |
| 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). | Day 14+2 |
| 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). | Day 14+2 |
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Inclusion Criteria:
Exclusion Criteria:
Are participating in any concurrent clinical or research study involving intervention or invasive ocular tests;
Are presbyopic or habitually use a reading addition for close work;
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.]
Meet the diagnosis of dry eye disease as per the following combination:
Meets the symptom criteria of Contact Lens Dry Eye Questionnaire (CLDEQ-8) score ≥12
And they show 1 of the following 2 signs:
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.]
Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Are a current wearer of DAILIES TOTAL1® daily disposable contact lenses;
Have known sensitivity to the diagnostic pharmaceutical sodium fluorescein to be used in the study;
Have undergone refractive error surgery;
Are a member of the Centre for Ocular Research & Education (CORE) directly involved in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones, PhD, FCOptom | Centre for Ocular Research & Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Ocular Research & Education | Waterloo | Ontario | N2L 3G1 | Canada |
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Out of the 41 participants that were enrolled, 35 met the inclusion critieria, and 35 were dispensed with the study treatment.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 3 people discontinued before the study could be completed. | Posted | Median | Full Range | score on a scale | Day 14+2 |
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|
2 weeks
Regular investigator assessment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jill Woods | Centre for Ocular Research and Education | (519) 888-4567 | 36743 | jwoods@uwaterloo.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2024 | Aug 11, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
|
|
| 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). | 3 people discontinued before the study could be completed. | Posted | Median | Full Range | score on a scale | Day 14+2 |
|
|
|
| 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). | 3 people discontinued before the study could be completed. | Posted | Median | Full Range | score on a scale | Day 14+2 |
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| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
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