Open label, 1-week daily disposable, dispensing study
Evaluate the clinical performance of habitual wearers of FILCON IV 1 sphere lenses when refitted with ocufilcon D asphere for 1 week of daily disposable wear.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
40
contact lens
contact lens
Optometry Research Group (GIO) Optics Department, University of Valencia
Valencia, Spain
Lens Fit, Centration - Filcon IV 1 and Ocufilcon D
Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable
Time frame: Baseline and 1 Week
Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D
Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Time frame: Baseline and 1 Week
Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D
Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement
Time frame: Baseline and 1 Week
Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D
Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.
Time frame: Baseline and 1 Week
Visual Acuity - Filcon IV 1 and Ocufilcon D
Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity).
Time frame: Baseline and 1 Week
Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel).
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Time frame: Baseline and 1 Week
Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness).
Time frame: Baseline and 1 Week
Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle).
Time frame: Baseline and 1 Week
Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied).
Time frame: Baseline and 1 Week
Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D.
Time frame: 1 Week
Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D
Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time frame: Baseline and 1 Week
Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D
Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time frame: Baseline and 1 Week
Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D
Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time frame: Baseline and 1 Week
Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D
Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time frame: Baseline and 1 Week
Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D
Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time frame: Baseline and 1 Week