Clinical Performance of Stenfilcon vs. Filcon II 3
The objective of this study is to compare the comfort and clinical performance of Stenfilcon vs. Filcon II 3 compared to subject's habitual contact lenses. The null hypothesis is that there is no difference in the clinical performance between the two sets of lenses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
60
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
University of Aston
Birmingham, West Midlands, United Kingdom
Daily and Comfortable Wearing Time
Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses.(The hours of average comfortable wearing time and average daily wearing time.)
Time frame: Baseline
Daily and Comfortable Wearing Time
Participant rating of lens Daily and Comfortable Wearing Time. Collected at 1 week wear for each lens.(The hours of average comfortable wearing time and average daily wearing time.)
Time frame: 1 week
Handling
Participant rating for lens handling. Collected at 1 week. (Insertion: 0-100, 0= could not get it in and 100= went in without a problem. Removal: 0= could not get it out and 100= came out without a problem. Blister: 0=impossible and 100=came out extremely easily).
Time frame: 1 Week
Comfort
Participant rating of lens comfort. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable,100=extreme comfort / cannot feel them at all)
Time frame: Baseline
Comfort
Participant rating for comfort. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).
Time frame: 1 Week
Dryness
Participant rating of lens dryness. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable, 100=extreme comfort/ cannot feel them at all)
Time frame: Baseline
Dryness
Participant rating for dryness. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).
Time frame: 1 Week
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Vision Quality
Participant rating of vision quality. Collected at baseline for habitual lens. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)
Time frame: Baseline
Vision Quality
Participant rating of vision quality. Collected at 1 week. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)
Time frame: 1 Week
Eye Whiteness
Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).
Time frame: Baseline
Eye Whiteness
Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).
Time frame: 1 Week
Overall Satisfaction
Participant rating for overall satisfaction. Collected at baseline for habitual lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).
Time frame: Baseline
Overall Satisfaction
Participant rating for overall satisfaction. Collected at 1 week for study lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).
Time frame: 1 Week
Visual Acuity logMAR
Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at baseline for habitual lens. logMAR.
Time frame: Baseline
Visual Acuity logMAR
Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at dispense for study lenses. logMAR.
Time frame: Dispense
Visual Acuity logMAR
Assessment of Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at 1 week for study lenses. logMAR
Time frame: 1 Week
Wettability
Participant rating for surface wettability. Collected at 1 week. Tear film analysis in seconds.
Time frame: 1 Week
Blood Vessel Coverage
Assessment of ocular health. Collected at baseline after removal of lenses. Percent of blood vessel coverage.
Time frame: Baseline
Blood Vessel Coverage
Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of blood vessel coverage.
Time frame: 1 Week
Conjunctival Redness
Assessment of ocular health. Collected at baseline after removal of lenses. Percentage of conjunctival redness.
Time frame: Baseline
Conjunctival Redness
Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of conjunctival redness.
Time frame: 1 Week
Corneal Staining
Assessment of ocular health. Collected at baseline after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )
Time frame: Baseline
Corneal Staining
Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )
Time frame: 1 Week
Conjunctival Staining
Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )
Time frame: 1 Week