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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refit | Experimental | Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verofilcon A contact lenses | Device | Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Comfort After Contact Lens Insertion | Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best). | Dispense Visit (Day 0) |
| Subjective Dryness After Contact Lens Insertion | Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best). | Dispense Visit (Day 0) |
| 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). | Dispense Visit (Day 0) |
| Subjective Comfort After Contact Lens Insertion | Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best). | Day 1 |
| Subjective Dryness After Contact Lens Insertion | Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best). | Day 1 |
| 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). | Day 1 |
| Subjective Comfort After Contact Lens Insertion | Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best). | Day 7 |
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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;
Is aphakic;
Has undergone refractive error surgery;
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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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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Comfort After Contact Lens Insertion | Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best). | Posted | Median | Full Range | score on a scale | Dispense Visit (Day 0) |
|
|
12-16 days
Regular investigator assessment. Adverse events were 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 | 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small fibre embdeed in superficial epithelium of left cornea | Eye disorders | Systematic Assessment |
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 12, 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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|
| Subjective Dryness After Contact Lens Insertion | Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best). | Day 7 |
| 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). | Day 7 |
| Subjective Comfort After Contact Lens Insertion | Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best). | Day 10 |
| Subjective Dryness After Contact Lens Insertion | Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best). | Day 10 |
| 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). | Day 10 |
| Subjective Comfort After Contact Lens Insertion | Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best). | Followup visit (occurring at a single visit any day from Day 12-16) |
| Subjective Dryness After Contact Lens Insertion | Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best). | Followup visit (occurring at a single visit any day from Day 12-16) |
| 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). | Followup visit (occurring at a single visit any day from Day 12-16) |
| 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). | Day 1 |
| 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). | Day 1 |
| 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). | Day 1 |
| 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). | Day 7 |
| 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). | Day 7 |
| 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). | Day 7 |
| 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). | Day 10 |
| 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). | Day 10 |
| 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). | Day 10 |
| 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). | Followup visit (occurring at a single visit any day from Day 12-16) |
| 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). | Followup visit (occurring at a single visit any day from Day 12-16) |
| 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). | Followup visit (occurring at a single visit any day from Day 12-16) |
| 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). | Day 1 |
| 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). | Day 1 |
| 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). | Day 1 |
| 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). | Day 7 |
| 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). | Day 7 |
| 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). | Day 7 |
| 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). | Day 10 |
| 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). | Day 10 |
| 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). | Day 10 |
| 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). | Followup visit (occurring at a single visit any day from Day 12-16) |
| 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). | Followup visit (occurring at a single visit any day from Day 12-16) |
| 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). | Followup visit (occurring at a single visit any day from Day 12-16) |
| years |
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| 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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| Primary | Subjective Dryness After Contact Lens Insertion | Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best). | Posted | Median | Full Range | score on a scale | Dispense Visit (Day 0) |
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| 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). | Posted | Median | Full Range | score on a scale | Dispense Visit (Day 0) |
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| Primary | Subjective Comfort After Contact Lens Insertion | Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best). | Posted | Mean | Full Range | score on a scale | Day 1 |
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| Primary | Subjective Dryness After Contact Lens Insertion | Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best). | Posted | Median | Full Range | score on a scale | Day 1 |
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| 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). | Posted | Median | Full Range | score on a scale | Day 1 |
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| Primary | Subjective Comfort After Contact Lens Insertion | Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best). | Posted | Median | Full Range | score on a scale | Day 7 |
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| Primary | Subjective Dryness After Contact Lens Insertion | Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best). | Posted | Median | Full Range | score on a scale | Day 7 |
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| 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). | Posted | Median | Full Range | score on a scale | Day 7 |
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| Primary | Subjective Comfort After Contact Lens Insertion | Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best). | Posted | Median | Full Range | score on a scale | Day 10 |
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| Primary | Subjective Dryness After Contact Lens Insertion | Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best). | Posted | Median | Full Range | score on a scale | Day 10 |
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| 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). | Posted | Median | Full Range | score on a scale | Day 10 |
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| Primary | Subjective Comfort After Contact Lens Insertion | Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best). | Posted | Median | Full Range | score on a scale | Followup visit (occurring at a single visit any day from Day 12-16) |
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| Primary | Subjective Dryness After Contact Lens Insertion | Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best). | Posted | Median | Full Range | score on a scale | Followup visit (occurring at a single visit any day from Day 12-16) |
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| 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). | Posted | Median | Full Range | score on a scale | Followup visit (occurring at a single visit any day from Day 12-16) |
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| 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). | Posted | Median | Full Range | score on a scale | Day 1 |
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| 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). | Posted | Median | Full Range | score on a scale | Day 1 |
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| 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). | Posted | Median | Full Range | score on a scale | Day 1 |
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| 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). | Posted | Median | Full Range | score on a scale | Day 7 |
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| 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). | Posted | Median | Full Range | score on a scale | Day 7 |
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| 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). | Posted | Median | Full Range | score on a scale | Day 7 |
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| 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). | Posted | Median | Full Range | score on a scale | Day 10 |
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| 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). | Posted | Median | Full Range | score on a scale | Day 10 |
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| 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). | Posted | Median | Full Range | score on a scale | Day 10 |
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| 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). | Posted | Median | Full Range | score on a scale | Followup visit (occurring at a single visit any day from Day 12-16) |
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| 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). | Posted | Median | Full Range | score on a scale | Followup visit (occurring at a single visit any day from Day 12-16) |
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| 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). | Posted | Median | Full Range | score on a scale | Followup visit (occurring at a single visit any day from Day 12-16) |
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| 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). | Posted | Median | Full Range | score on a scale | Day 1 |
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| 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). | Posted | Median | Full Range | score on a scale | Day 1 |
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| 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). | Posted | Median | Full Range | score on a scale | Day 1 |
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| 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). | Posted | Median | Full Range | score on a scale | Day 7 |
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| 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). | Posted | Median | Full Range | score on a scale | Day 7 |
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| 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). | Posted | Median | Full Range | score on a scale | Day 7 |
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| 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). | Posted | Median | Full Range | score on a scale | Day 10 |
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| 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). | Posted | Median | Full Range | score on a scale | Day 10 |
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| 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). | Posted | Median | Full Range | score on a scale | Day 10 |
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| 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). | Posted | Median | Full Range | score on a scale | Followup visit (occurring at a single visit any day from Day 12-16) |
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| 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). | Posted | Median | Full Range | score on a scale | Followup visit (occurring at a single visit any day from Day 12-16) |
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| 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). | Posted | Median | Full Range | score on a scale | Followup visit (occurring at a single visit any day from Day 12-16) |
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| 32 |
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| 32 |
| 1 |
| 32 |
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