Evaluation of the clinical performance of two toric contact lenses in a 2-week, single masked (subject), daily wear, randomized, bilateral, parallel group study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
276
silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
Camp Eye Care Clinic
North Little Rock, Arkansas, United States
James R. Dugue, O.D.
Mission Viejo, California, United States
Lens Orientation
Proportion of eyes with lens orientation within 5 degrees of optimal
Time frame: 1 minute after insertion
Lens Stability
Lens stability is measured as the amount of rotation induced from blink after the lens has settled.
Time frame: 10-15 minutes after insertion
Subjective Comfort
Subjective comfort was derived from a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. \>0 = comfortable, \< 0 = uncomfortable. Combined measures from Week 1 and Week 5.
Time frame: 2 weeks of lens wear
Time to Fit Lens
Time required for the optometrist to fit the lens.
Time frame: after lens insertion
Subjective Lens Vision
A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response was used to derive vision outcomes. \>0 = satisfactory vision, \< 0 = unsatisfactory vision. Analysis is performed on combined 1 week and 2 week data.
Time frame: measured at 1 and 2 weeks
Overall Corneal Staining
National Eye Institute 0-3 Scale: Grade 0 = Normal, Grade 1 = Mild, superficial stippling, Grade 2 = Moderate, punctuate staining including superficial abrasion of the cornea, Grade 3 = Severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.
Time frame: After 2 weeks use
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