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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verofilcon A / Etafilcon A | Experimental | The participant will wear Verofilcon A in their right eye and Etafilcon A in their left eye. |
|
| Etafilcon A / Verofilcon A | Experimental | The participant will wear Etafilcon A in their right eye and Verafilcon A in their left eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verafilcon A | Device | Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| 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. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
Is participating in any concurrent clinical or research study;
Has any known active* ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);
Is aphakic;
Has undergone refractive error surgery;
Has taken part in another clinical research study within the last 14 days;
Any ocular and/or systemic conditions or concomitant medication to contraindicate contact lens wear or be expected to interfere with the primary outcome variables.
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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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Of 40 enrolled participants, 36 met inclusion criteria and were randomized to treatment.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| 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 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. | Posted | Median | Full Range | score on a scale | Baseline |
|
Average of 1 week
An adverse event was defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.
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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 | Ocular Adverse Events Only: Verofilcon A (Per Intervention) | The participant will wear Verofilcon A in one eye. Verafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia) Ocular adverse events are reported per intervention. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular irritation | Eye disorders | Systematic Assessment | Ocular irritation due to lens wear. Mild increase in redness. |
The study was affected by the COVID-19 pandemic, which resulted in a mandated site closure to limit the spread of COVID-19.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jill Woods | Centre for Ocular Research and Education | 5198884567 | 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 | Dec 2, 2019 | Nov 10, 2022 | 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 and Investigators will be masked to which lens type (brand) the participants will be wearing in each eye during the study.
|
| Etafilcon A | Device | Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia) |
|
|
| University closure due to COVID-19 |
|
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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) |
|
|
|
| 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. | Posted | Median | Full Range | score on a scale | Baseline |
|
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Ocular Adverse Events Only: Etafilcon A (Per Intervention) | The participant will wear Etafilcon A in the other eye. Etafilcon A: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia) Ocular adverse events are reported per intervention. | 0 | 36 | 0 | 36 | 1 | 36 |
| EG002 | Systemic Adverse Events: Verofilcon A and Etafilcon A | The participant will wear Verofilcon A in one eye and Etafilcon A in the other 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) | 0 | 36 | 0 | 36 | 1 | 36 |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
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| 0.924 |
| Other |