The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses.
The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses for 4 weeks of daily wear.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Contact Lens
Contact Lens
Optometry Clinic, National Autonomous University
Mexico City, Mexico
Lens Centration for Somofilcon A (Habitual) Lens
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time frame: Baseline
Lens Centration for Somofilcon A (Habitual) Lens
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time frame: 4- weeks
Lens Centration for Fanfilcon A (Test) Lens
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time frame: Baseline
Lens Centration for Fanfilcon A (Test) Lens
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time frame: 2-weeks
Lens Centration for Fanfilcon A (Test) Lens
Lens Centration was measured using a 3-point scale(1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time frame: 4- weeks
Lens Corneal Coverage for Somofilcon A (Habitual) Lens
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time frame: Baseline
Lens Corneal Coverage for Somofilcon A (Habitual) Lens
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time frame: 4 -weeks
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Lens Corneal Coverage for Fanfilcon A (Test) Lens
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time frame: Baseline
Lens Corneal Coverage for Fanfilcon A (Test) Lens
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time frame: 2-weeks
Lens Corneal Coverage for Fanfilcon A (Test) Lens
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time frame: 4-weeks
Percentage of Lens Tightness for Somofilcon A (Habitual) Lens
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Time frame: Baseline
Percentage of Lens Tightness for Somofilcon A (Habitual) Lens
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Time frame: 4-Weeks
Percentage of Lens Tightness for Fanfilcon A (Test) Lens
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Time frame: Baseline
Percentage of Lens Tightness for Fanfilcon A (Test) Lens
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Time frame: 2-Weeks
Percentage of Lens Tightness for Fanfilcon A (Test) Lens
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Time frame: 4-Weeks
Post-Blink Movement for Somofilcon A (Habitual) Lens
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Time frame: Baseline
Post-Blink Movement for Somofilcon A (Habitual) Lens
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Time frame: 4-weeks
Post-Blink Movement for Fanfilcon A (Test) Lens
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Time frame: Baseline
Post-Blink Movement for Fanfilcon A (Test) Lens
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Time frame: 2-weeks
Post-Blink Movement for Fanfilcon A (Test) Lens
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Time frame: 4-weeks
Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens
Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)
Time frame: Baseline
Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens
Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)
Time frame: 4-weeks
Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens
Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)
Time frame: Baseline
Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens
Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)
Time frame: 2-weeks
Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens
Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)
Time frame: 4-weeks
Average Daily Wearing Time - Somofilcon A (Habitual) Lens
Average Daily Wearing Time for somofilcon A (Habitual) lens - measured by time hours/day
Time frame: 4-weeks
Average Daily Wearing Time - Fanfilcon A (Test) Lens
Average daily wearing time for fanfilcon A (test) lens was measured in hours/day
Time frame: 2-weeks
Average Daily Wearing Time - Fanfilcon A (Test) Lens
Average daily wearing time for fanfilcon A (test) lens was measured in hours/day
Time frame: 4-weeks
Average Comfortable Wearing Time - Somofilcon A (Habitual) Lens
Average Comfortable Wearing Time - somofilcon A (habitual) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.
Time frame: 4 weeks
Average Comfortable Wearing Time - Fanfilcon A (Test) Lens
Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.
Time frame: 2 weeks
Average Comfortable Wearing Time - Fanfilcon A (Test) Lens
Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.
Time frame: 4 weeks