The purpose of this 4-week dispensing trial is to evaluate and compare an investigational soft contact lens worn on a daily disposable basis with three other soft contact lenses also worn on a daily disposable basis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
130
Investigational silicone hydrogel, single vision contact lens for daily wear, daily disposable use
Commercially marketed silicone hydrogel, single vision contact lens for daily wear, daily disposable use
Commercially marketed hydrogel, single vision contact lens for daily wear, daily disposable use
CIBA VISION Research Clinic
Duluth, Georgia, United States
CIBA VISION Research Clinic
Großwallstadt, Germany
Overall Comfort
Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 4 weeks
Vision Quality During the Day
Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 4 weeks
Overall Handling
Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 4 weeks
Dryness Throughout the Day
Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Time frame: 4 weeks
Average Daily Wear Time
Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear.
Time frame: 4 weeks
Lens Fit
Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight.
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Commercially marketed (Europe) silicone hydrogel, single vision contact lens for daily wear, daily disposable use
Time frame: 4 weeks
Corrected Visual Acuity
Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.
Time frame: 4 weeks
Overall Satisfaction
Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied.
Time frame: 4 weeks