The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A aspheric lenses after a refit with fanfilcon A sphere lenses for 4 weeks of daily wear.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
42
Bilateral daily wear of methafilcon A contact lenses
Bilateral daily wear of fanfilcon A contact lenses
Optometry Clinic, National Autonomous University
Mexico City, Mexico
Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses
Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time frame: Baseline
Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses
Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time frame: 4 weeks
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses
Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time frame: Baseline
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses
Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time frame: 2 weeks
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses
Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time frame: 4 weeks
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses
Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Time frame: Baseline
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses
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Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Time frame: 4 weeks
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses
Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Time frame: Baseline
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses
Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Time frame: 2 weeks
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses
Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Time frame: 4 weeks
Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses
Post-blink movement, was rated at each visit using a 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 Assessment by the Investigator - Methafilcon A Contact Lenses
Post-blink movement, was rated at each visit using a 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 Assessment by the Investigator - Fanfilcon A Contact Lenses
Post-blink movement, was rated at each visit using a 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 Assessment by the Investigator - Fanfilcon A Contact Lenses
Post-blink movement, was rated at each visit using a 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 Assessment by the Investigator - Fanfilcon A Contact Lenses
Post-blink movement, was rated at each visit using a 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
Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses
Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Time frame: Baseline
Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses
Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Time frame: 4 weeks
Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses
Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Time frame: Baseline
Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses
Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Time frame: 2 weeks
Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses
Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Time frame: 4 weeks
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses
Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Time frame: Baseline
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses
Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Time frame: 4 weeks
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses
Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Time frame: Baseline
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses
Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Time frame: 2 weeks
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses
Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Time frame: 4 weeks
Average Daily Wearing Time - Methafilcon A Contact Lenses
Average daily wearing time response by the subject
Time frame: 4 weeks
Average Daily Wearing Time - Fanfilcon A Contact Lenses
Average daily wearing time response by the subject.
Time frame: 2 weeks
Average Daily Wearing Time - Fanfilcon A Contact Lenses
Average daily wearing time response by the subject
Time frame: 4 weeks
Average Comfortable Wearing Time - Methafilcon A Contact Lenses
Average comfortable wearing time - response by the subject
Time frame: 4 weeks
Average Comfortable Wearing Time - Fanfilcon A Contact Lenses
Average comfortable wearing time - response by the subject
Time frame: 2 weeks
Average Comfortable Wearing Time - Fanfilcon A Contact Lenses
Average comfortable wearing time - response by the subject
Time frame: 4 weeks