The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.
This study is a 13-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
14
contact lens
contact lens
CORL, Indiana University
Bloomington, Indiana, United States
Visual Acuity
Visual acuity was measured at distance, intermediate and near conditions for test and control lens was assessed by LogMAR.
Time frame: 4 days
Visual Performance
Subjective assessment of visual performance for test and control lens is assessed on a scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time).
Time frame: 4 days
Subjective Ratings for Comfort
Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Time frame: Baseline
Subjective Ratings for Comfort
Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Time frame: 4 days
Subjective Ratings for Dryness
Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).
Time frame: Baseline
Subjective Ratings for Dryness
Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).
Time frame: 4 days
Lens Handling
Subjective ratings for handling (ease of insertion and removal) was assessed for test and control lens on a scale 0-100, 0=very difficult to handle, 100=easy to handle).
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Time frame: 4 Days
Average Daily Wearing Time
Average daily wearing time for test and control lens is assessed in hours.
Time frame: 4 days
Lens Fit
Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 grading system in 0.25 steps where 0 represented very poor fit.
Time frame: 4 days
Bulbar Hyperemia
Bulbar hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.
Time frame: 4 days
Limbal Hyperemia
Limbal hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.
Time frame: 4 days
Subjective Satisfaction
Subjective satisfaction for test and control lens was assessed on a scale 0-100, 0=extremely dissatisfied, 100=very satisfied)
Time frame: 4 days
Subjective Preference for Near Vision
Subjective preference for near vision for test and control contact lenses. comfort, vision, handling, satisfaction.
Time frame: 4 days
Subjective Preference for Distance Vision
Subjective preference for distance vision for test and control contact lenses.
Time frame: 4 days
Subjective Preference for Intermediate Vision
Subjective preference for intermediate vision for test and control contact lenses.
Time frame: 4 days
Subjective Preference for Overall Vision
Subjective preference for overall vision for test and control contact lenses.
Time frame: 4 days
Subjective Preference for Comfort
Subjective preference for comfort for test and control contact lenses.
Time frame: 4 days
Subjective Overall Lens Preference
Subjective overall lens preference for test and control contact lenses.
Time frame: 4 days