To evaluate the clinical performance of an investigational silicone-hydrogel lens when worn on a daily wear modality over two weeks of lens wear.
This was a randomized, bilateral, 2 week cross over, double-masked, dispensing study comparing Sapphire test lens against the senofilcon A control lens. This study results were not used to support design validation of the test lens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
silicone-hydrogel contact lens
contact lens
Clinical Research Center, University of California, Berkeley
Berkeley, California, United States
Center for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada
Vision Quality
Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Time frame: Baseline (10 minutes post lens settling at dispense)
Vision Quality
Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Time frame: 2 weeks - During the Day
Vision Quality
Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Time frame: 2 weeks - End of Day
Subjective Rating for Comfort.
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Time frame: Baseline - 10 minutes post lens settling
Subjective Rating for Comfort.
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Time frame: 2-weeks - During the Day
Subjective Rating for Comfort.
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Time frame: 2-weeks - End of Day
Lens Surface Wettability
Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)
Time frame: Baseline (10 minutes post lens settling)
Lens Surface Wettability
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)
Time frame: 2 weeks
Surface Deposits
Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = \<5 deposits; 2 = \>5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits \>0.5mm or film \> 75% of surface)
Time frame: Baseline (10 minutes post lens settling)
Surface Deposits
Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = \<5 deposits; 2 = \>5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits \>0.5mm or film \> 75% of surface)
Time frame: 2-weeks
Lens Handling (Ease of Insertion)
Lens handling - ease of insertion of the lenses. Scale 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye.
Time frame: 2 weeks
Lens Handling (Ease of Removal)
Lens handling - ease of removal of the lenses. Scale 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye.
Time frame: 2 weeks
Subjective Preference for Comfort.
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Time frame: Baseline - 10 minutes post lens settling
Subjective Preference for Comfort.
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Time frame: 2 weeks