Optometry Clinic, National Autonomous University
Mexico City, Mexico
NCT Number: NCT04050605
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.
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Notify Me18 year–40 year
All sexes
Interventional
Not applicable
Mexico City, Mexico
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Contact Lens
Other names: Habitual lens
Contact Lens
Other names: Test Lens
Time frame: Baseline
Lens Centration assessed using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time frame: 4 weeks
Lens Centration (using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time frame: Baseline
Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time frame: 2-weeks
Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time frame: 4-weeks
Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time frame: Baseline
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time frame: 4-weeks
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time frame: Baseline
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time frame: 2-weeks
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time frame: 4-weeks
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time frame: Baseline
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)
Time frame: 4-weeks
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).
Time frame: Baseline
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).
Time frame: 2-weeks
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).
Time frame: 4-weeks
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).
Time frame: Baseline
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).
Time frame: 4-weeks
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).
Time frame: Baseline
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).
Time frame: 2-weeks
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).
Time frame: 4-weeks
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).
Time frame: 4 weeks
Average Daily Wearing Time for somofilcon A toric (habitual) lens measured by hours/day.
Time frame: 2 weeks
Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.
Time frame: 4 weeks
Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.
Time frame: 4 weeks
Average Comfortable Wearing Time - somofilcon A toric (habitual) lens measured by hours/day
Time frame: 2 weeks
Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.
Time frame: 4 weeks
Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.
CooperVision, Inc.
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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