This study will investigate performance criteria over one week of daily wear to determine if the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms of subjective ratings and of visual performance. The study test lens was not the final optical design and the study results were not used for the design validation.
This will be double-masked, randomized, bilateral crossover study comparing the Study Test lens against the comfilcon A control lens, each worn over one week of daily wear. The study test lens was not the final optical design and the study results were not used for the design validation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
30
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Bloomington, Indiana, United States
Binocular Distance Visual Acuity (VA) - High Illumination High Contrast
Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)
Time frame: Baseline - After 5 minutes of lens settling
Binocular Distance Visual Acuity (VA) -High Illumination High Contrast
Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)
Time frame: 1 week
Binocular Near Visual Acuity (VA) - High Illumination High Contrast
Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)
Time frame: Baseline - after 5 minutes of lens dispense
Binocular Near Visual Acuity (VA) - High Illumination High Contrast
Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)
Time frame: 1-week
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Time frame: Baseline (After 5 minutes of lens settling)
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Time frame: 1 week
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
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Time frame: Baseline (after 5 minutes of lens settling)
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Time frame: 1week
Subjective Ratings for Distance Quality of Vision
Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Distance Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)
Time frame: 1 week
Subjective Ratings for Intermediate Quality of Vision
Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Intermediate Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)
Time frame: 1 week
Subjective Ratings for Near Quality of Vision
Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Near Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)
Time frame: 1 week
Post Blink Movement -
Post blink movement was assessed by the investigator by the amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Time frame: Baseline (After 5 minutes of lens dispense)
Post Blink Movement
Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Time frame: 1 week
Push - Up Test for Lens Tightness
Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
Time frame: Baseline (After 5 minutes of lens dispense)
Push - Up Test for Lens Tightness
Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
Time frame: 1 week
Lens Mobility Rating
Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (\>1mm) on versions in all directions in 0.25 steps
Time frame: Baseline (after 5 minutes of lens dispense)
Lens Mobility Rating
Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (\>1mm) on versions in all directions in 0.25 steps
Time frame: 1 week
Overall Lens Fit Acceptance
Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
Time frame: Baseline (After 5 minutes of lens dispense)
Overall Lens Fit Acceptance
Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn,, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
Time frame: 1 week
Subjective Lens Preference - Distance Vision
Patient subjective preference: Phenacite lens, comfilcon A or No Preference
Time frame: 1 week
Subjective Lens Preference -Overall Vision Preference
Patient subjective preference: Phenacite test lens, comfilcon A or No Preference
Time frame: 1 week
Subjective Lens Preference - Comfort
Patient subjective preference: Phenacite test lens, comfilcon A or No Preference
Time frame: 1 week
Subjective Overall Lens Preference
Patient subjective overall preference: Phenacite test lens, comfilcon A or No Preference
Time frame: 1 week