This study was conducted to evaluate the clinical performance of an investigational silicone-hydrogel lens against Senofilcon A toric lens. The study results were not used for design validation of the investigational product.
This will be a randomized, bilateral, 2-week cross-over, double-masked, dispensing study comparing the investigational test lens against the Senofilcon A Toric for Astigmatism control lens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
23
Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair
Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair
Family Eye Care Center
Campbell, California, United States
Subjective Ratings for Comfort
Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)
Time frame: Baseline (10 minutes post lens settling)
Subjective Ratings for Comfort
Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)
Time frame: 2 weeks
Subjective Ratings for Comfort Preference
Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference
Time frame: Baseline (10 minutes post lens settling)
Subjective Ratings for Comfort Preference
Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference
Time frame: 2 weeks
Subjective Assessment of Visual Quality
Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)
Time frame: Baseline (10 minutes post lens settling)
Subjective Assessment of Visual Quality
Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)
Time frame: 2 weeks
Subjective Assessment of Overall Satisfaction
Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)
Time frame: Baseline (10 minutes post lens settling)
Subjective Assessment of Overall Satisfaction
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Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)
Time frame: 2 weeks
Subjective Overall Preference
Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference
Time frame: Baseline (10 minutes post lens settling)
Subjective Overall Preference
Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference
Time frame: 2 weeks