The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
52
Silicone hydrogel contact lens
Silicon Hydrogel contact lens
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Salem, Virginia, United States
Visual Acuity Monocular
Snellen monocular visual acuity measurement
Time frame: after 1 week of lens wear
Visual Acuity Binocular
Snellen binocular visual acuity measurement
Time frame: after 1 week of lens wear
Subjective Assessment of Lens Comfort
Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Time frame: after 1 week of lens wear
Subjective Assessment of Quality of Vision
Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Time frame: after 1 week of lens wear
Limbal Redness
Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Time frame: after 1 week of lens wear
Bulbar Redness
Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Time frame: after 1 week of lens wear
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Subjective Assessment of Lens Comfort
Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Time frame: 10 minutes after lens insertion at time of initial lens fitting