This study investigated the performance criteria over one week of daily wear to determine if the comfilcon A asphere lens (test) performed equivalently to the comfilcon A sphere (control) in terms of measurement and subjective ratings of visual performance.
This study was a prospective, single site, daily wear, double masked, randomized bilateral cross over dispensing study of binocular wear of comfilcon A asphere lens (test) and comfilcon A sphere lens (control) over 1 week of daily wear.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
contact lens
contact lens
University of California
Berkeley, California, United States
CORL, Indiana University
Bloomington, Indiana, United States
Center for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada
Distance Visual Acuity (VA) - High Illumination
Distance visual acuity High Illumination was assessed using logMAR
Time frame: Baseline (after 10 minutes of lens dispense)
Distance Visual Acuity (VA) - High Illumination
Distance visual acuity High Illumination was assessed using logMAR
Time frame: 1 week
Near Visual Acuity (VA) - High Illumination
Near Visual Acuity (VA) - High Illumination assessed using logMAR
Time frame: Baseline (after 10 minutes of lens dispense)
Near Visual Acuity (VA) - High Illumination
Near Visual Acuity (VA) - High Illumination assessed using logMAR
Time frame: 1 week
Distance Visual Acuity (VA) - Low Illumination
Distance Visual Acuity (VA) - Low Illumination assessed using logMAR
Time frame: Baseline (after 10 minutes of lens dispense)
Distance Visual Acuity (VA) - Low Illumination
Distance Visual Acuity (VA) - Low Illumination assessed using logMAR
Time frame: 1 week
Near Visual Acuity (VA) - Low Illumination
Near Visual Acuity (VA) - Low illumination assessed using logMAR
Time frame: Baseline (after 10 minutes of lens dispense)
Near Visual Acuity (VA) - Low Illumination
Near Visual Acuity (VA) - Low illumination assessed using logMAR
Time frame: 1 week
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Quality of Distance Vision
Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time frame: Baseline (after 10 minutes of lens dispense)
Quality of Distance Vision
Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time frame: 1 week
Quality of Near Vision
Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time
Time frame: Baseline (After 10 minutes of lens dispense)
Quality of Near Vision
Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time
Time frame: 1 week
Quality of Vision With Digital Device Use
Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time frame: Baseline (After 10 minutes of lens dispense)
Quality of Vision With Digital Device Use
Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time frame: 1 week
Quality of Intermediate Vision
Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time frame: Baseline (After 10 minutes of lens dispense)
Quality of Intermediate Vision
Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time frame: 1 week
Overall Vision Quality
Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time frame: Baseline (After 10 minutes of lens dispense)
Overall Vision Quality
Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time frame: 1 week
Biomicroscopy Findings - Bulbar Hyperemia
Bulbar hyperemia assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)
Time frame: 1 week
Biomicroscopy Findings- Limbal Hyperemia
Investigator assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)
Time frame: 1 week
Biomicroscopy Findings - Corneal Staining Extent
Investigator Assessment on Biomicroscopy Findings - Corneal Staining Extent on a scale of 0-4 : 0=No staining, 1=1-15% of area, 2=16-30% of area, 3=31-45% of area, 4= \>45% of area
Time frame: 1 week
Ghosting - Distance Vision
Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable
Time frame: 1 week
Ghosting - Near Vision
Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable
Time frame: 1 week
Overall Comfort
Patient subjective scoring using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.
Time frame: Baseline (After 10 minutes of lens dispense)
Overall Comfort
Patient subjective scoring for overall comfort using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.
Time frame: 1 week
Overall Dryness
Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.
Time frame: Baseline (after 10 minutes of lens dispense)
Overall Dryness
Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.
Time frame: 1 week
Lens Preference - Overall Vision Preference
Subjective rating of lens preference for overall vision preference (Phenacite, comfilcon A, No preference)
Time frame: 1 week
Subjective Ratings of Change in Frequency of Tiredness
Subjective rating of change in eye fatigue frequency of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time frame: 1 week
Subjective Ratings of Change in Severity of Tiredness
Subjective rating of change in eye fatigue severity of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time frame: 1 week
Subjective Ratings of Change in Bothersome Rating for Tiredness
Subjective rating of change in eye fatigue bothersome rating for tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time frame: 1 week
Subjective Ratings of Change in Frequency of Dryness
Subjective rating of change in eye fatigue frequency of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time frame: 1 week
Subjective Ratings of Change in Severity of Dryness
Subjective rating of change in eye fatigue severity of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time frame: 1 week
Subjective Ratings of Change in Bothersome Rating of Dryness
Subjective rating of change in eye fatigue bothersome rating for dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time frame: 1 week
Subjective Questionnaire Response - Eye Strain
Subjective questionnaire response for " My eyes don't feel strained while wearing these lenses" - Agree, Disagree
Time frame: 1 week
Subjective Questionnaire Response - Eye Feel Good
Subjective questionnaire response for " These lenses make my eyes feel good" - Agree, Disagree
Time frame: 1 week
Subjective Questionnaire Response - Eye Feel Relaxed
Subjective questionnaire response for " These lenses make my eyes feel relaxed" - Agree, Disagree
Time frame: 1 week
Subjective Questionnaire Response - Vision
Subjective questionnaire response for " These lenses help my vision" - Agree, Disagree
Time frame: 1 week
Subjective Questionnaire Response - Eye Tired
Subjective questionnaire response for " These lenses make my eyes feel less tired" - Agree, Disagree
Time frame: 1 week