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The aim of this prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear.
The aim of this prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear.
This is a prospective, subject masked; bilateral, 1-month refit study comparing the fitting characteristics of Clariti Toric silicone hydrogel lenses, (somofilcon A); against Avaira Vitality silicone hydrogel Toric lenses (fanfilcon A).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| somofilcon A toric (habitual), then fanfilcon toric (test) | Experimental | Participants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somofilcon A toric contact lens | Device | Contact Lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Centration - Somofilcon A Toric (Habitual) Lens | Lens Centration assessed using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Baseline |
| Lens Centration - Somofilcon A Toric (Habitual) Lens | Lens Centration (using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 4 weeks |
| Lens Centration - Fanfilcon A Toric Lens | Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Baseline |
| Lens Centration - Fanfilcon A Toric Lens | Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 2-weeks |
| Lens Centration - Fanfilcon A Toric Lens | Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 4-weeks |
| Corneal Coverage - Somofilcon A Toric (Habitual ) Lens | Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage) | Baseline |
| Corneal Coverage - Somofilcon A Toric (Habitual ) Lens | Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage) |
| Measure | Description | Time Frame |
|---|---|---|
| Average Daily Wearing Time - Somofilcon A Toric (Habitual) Lens | Average Daily Wearing Time for somofilcon A toric (habitual) lens measured by hours/day. | 4 weeks |
| Average Daily Wearing Time - Fanfilcon A Toric Lens |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruben Velázquez Guerrero, MSc., FIACLE | School of Optometry, National Autonomous University (UNAM), Mexico City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optometry Clinic, National Autonomous University | Mexico City | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | Somofilcon A Toric (Habitual), Then Fanfilcon Toric (Test) | Participants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens. somofilcon A toric contact lens: Contact Lens fanfilcon A toric contact lens: Contact Lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Somofilcon A Toric (Habitual), Then Fanfilcon Toric (Test) | Participants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens. somofilcon A toric contact lens: Contact Lens fanfilcon A toric contact lens: Contact Lens |
| 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 | Lens Centration - Somofilcon A Toric (Habitual) Lens | Lens Centration assessed using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Number | percentage of lenses | Baseline |
|
|
From dispense up to 4-weeks for each lens type, a total of 8-weeks.
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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 | Somofilcon A Toric (Habitual) Lens | Participants are habitual wearers of somofilcon A toric lens for 4-weeks somofilcon A toric contact lens: Contact Lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, O.D, MSc., FAAO | CooperVision. Inc | 9256213761 | javega@coopervision.com |
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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 | Mar 4, 2019 | Aug 5, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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First pair of study lenses (habitual lenses - somofilcon A toric) will be dispensed and worn for 4-weeks of daily wear, then second pair of lenses (test lenses - fanfilcon A toric) will be dispensed and worn for 4-weeks for daily wear.
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Study lenses will be transferred, by an assistant, out of their packaging to unmarked new contact lens cases filled with preservative free sterile saline just prior to dispensing to maintain subject masking of the study lenses.
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| fanfilcon A toric contact lens | Device | Contact Lens |
|
|
| 4-weeks |
| Corneal Coverage - Fanfilcon A Toric Lens | Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage) | Baseline |
| Corneal Coverage - Fanfilcon A Toric Lens | Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage) | 2-weeks |
| Corneal Coverage - Fanfilcon A Toric Lens | Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage) | 4-weeks |
| Post-Blink Movement - Somofilcon A Toric (Habitual) Lens | Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement) | Baseline |
| Post-Blink Movement - Somofilcon A Toric (Habitual) Lens | Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | 4-weeks |
| Post-Blink Movement - Fanfilcon A Toric Lens | Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | Baseline |
| Post-Blink Movement - Fanfilcon A Toric Lens | Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | 2-weeks |
| Post-Blink Movement - Fanfilcon A Toric Lens | Post-Blink movement (0-4 Scale,0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | 4-weeks |
| Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens | Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect). | Baseline |
| Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens | Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect). | 4-weeks |
| Overall Lens Fit Acceptance - Fanfilcon A Toric Lens | Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect). | Baseline |
| Overall Lens Fit Acceptance - Fanfilcon A Toric Lens | Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect). | 2-weeks |
| Overall Lens Fit Acceptance - Fanfilcon A Toric Lens | Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect). | 4-weeks |
Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.
| 2 weeks |
| Average Daily Wearing Time - Fanfilcon A Toric Lens | Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day. | 4 weeks |
| Average Comfortable Wearing Time - Somofilcon A Toric (Habitual) Lens | Average Comfortable Wearing Time - somofilcon A toric (habitual) lens measured by hours/day | 4 weeks |
| Average Comfortable Wearing Time - Fanfilcon A Toric Lens | Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day. | 2 weeks |
| Average Comfortable Wearing Time - Fanfilcon A Toric Lens | Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day. | 4 weeks |
| 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 |
|
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| Primary | Lens Centration - Somofilcon A Toric (Habitual) Lens | Lens Centration (using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Number | percentage of lenses | 4 weeks |
|
|
|
| Primary | Lens Centration - Fanfilcon A Toric Lens | Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Number | percentage of lenses | Baseline |
|
|
|
| Primary | Lens Centration - Fanfilcon A Toric Lens | Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Number | percentage of lenses | 2-weeks |
|
|
|
| Primary | Lens Centration - Fanfilcon A Toric Lens | Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Number | percentage of lenses | 4-weeks |
|
|
|
| Primary | Corneal Coverage - Somofilcon A Toric (Habitual ) Lens | Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage) | Posted | Number | percentage of lenses | Baseline |
|
|
|
| Primary | Corneal Coverage - Somofilcon A Toric (Habitual ) Lens | Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage) | Posted | Number | percentage of lenses | 4-weeks |
|
|
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| Primary | Corneal Coverage - Fanfilcon A Toric Lens | Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage) | Posted | Number | percentage of lenses | Baseline |
|
|
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| Primary | Corneal Coverage - Fanfilcon A Toric Lens | Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage) | Posted | Number | percentage of lenses | 2-weeks |
|
|
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| Primary | Corneal Coverage - Fanfilcon A Toric Lens | Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage) | Posted | Number | percentage of lenses | 4-weeks |
|
|
|
| Primary | Post-Blink Movement - Somofilcon A Toric (Habitual) Lens | Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Post-Blink Movement - Somofilcon A Toric (Habitual) Lens | Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | Posted | Mean | Standard Deviation | units on a scale | 4-weeks |
|
|
|
| Primary | Post-Blink Movement - Fanfilcon A Toric Lens | Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Post-Blink Movement - Fanfilcon A Toric Lens | Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | Posted | Mean | Standard Deviation | units on a scale | 2-weeks |
|
|
|
| Primary | Post-Blink Movement - Fanfilcon A Toric Lens | Post-Blink movement (0-4 Scale,0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | Posted | Mean | Standard Deviation | units on a scale | 4-weeks |
|
|
|
| Primary | Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens | Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens | Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect). | Posted | Mean | Standard Deviation | units on a scale | 4-weeks |
|
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| Primary | Overall Lens Fit Acceptance - Fanfilcon A Toric Lens | Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
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| Primary | Overall Lens Fit Acceptance - Fanfilcon A Toric Lens | Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect). | Posted | Mean | Standard Deviation | units on a scale | 2-weeks |
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| Primary | Overall Lens Fit Acceptance - Fanfilcon A Toric Lens | Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect). | Posted | Mean | Standard Deviation | units on a scale | 4-weeks |
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| Secondary | Average Daily Wearing Time - Somofilcon A Toric (Habitual) Lens | Average Daily Wearing Time for somofilcon A toric (habitual) lens measured by hours/day. | Posted | Mean | Standard Deviation | hours/day | 4 weeks |
|
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| Secondary | Average Daily Wearing Time - Fanfilcon A Toric Lens | Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day. | Posted | Mean | Standard Deviation | hours/day | 2 weeks |
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| Secondary | Average Daily Wearing Time - Fanfilcon A Toric Lens | Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day. | Posted | Mean | Standard Deviation | hours/day | 4 weeks |
|
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|
| Secondary | Average Comfortable Wearing Time - Somofilcon A Toric (Habitual) Lens | Average Comfortable Wearing Time - somofilcon A toric (habitual) lens measured by hours/day | Posted | Mean | Standard Deviation | hours/day | 4 weeks |
|
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| Secondary | Average Comfortable Wearing Time - Fanfilcon A Toric Lens | Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day. | Posted | Mean | Standard Deviation | hours/day | 2 weeks |
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| Secondary | Average Comfortable Wearing Time - Fanfilcon A Toric Lens | Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day. | Posted | Mean | Standard Deviation | hours/day | 4 weeks |
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| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Fanfilcon A Toric Contact Lens | Participants were refitted with fanfilcon A toric lens for 4-weeks fanfilcon A toric contact lens: Contact Lens | 0 | 40 | 0 | 40 | 0 | 40 |
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