The purpose of this study is to evaluate and compare the clinical performance of two toric contact lenses amongst 110 subjects, 2-week, single masked (subject), daily wear, randomized, bilateral, crossover study; 4 weeks duration. Hypotheses include equal or better performance of the test lens over the control lenses for comfort, vision, and toric fit characteristics as well as corneal integrity
Up to 7 sites in the US will participate. Each investigator will have both test and control lens types. There will be a maximum of 6 scheduled visits: Visit 1: Habitual lens evaluation / Baseline / Trial fitting Visit 2: Dispensing (to be combined with Visit 1 where possible), Visit 3: Questionnaire only (no exam) 7 days (±2) after dispensing, Visit 4: 2 week follow-up 14 days (±3) after dispensing, and dispense second lens type, Visit 5: Questionnaire only (no exam) 7 days (±2) after 2nd lens dispense, Visit 6: 2 week follow-up 14 days (±3) after 2nd lens dispense
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
89
silicone hydrogel toric lens, 2 wk replacement, daily wear
hydrogel toric lens, 2 wk replacement, daily wear
Ted Brink and Associates
Jacksonville, Florida, United States
Eola Eyes
Orlando, Florida, United States
Clayton Eye Center
Morrow, Georgia, United States
The Koetting Associates Inc.
St Louis, Missouri, United States
Lens Orientation Within 5 Degrees
Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.
Time frame: 1 minute after insertion
Lens Stability
Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.
Time frame: 10-15 minutes after insertion
Subjective Lens Comfort
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, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. \>0=comfortable, \<0=uncomfortable.
Time frame: 1 and 2 weeks
Subjective 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. The analysis shows the difference in outcome between the test and control. \>0=satisfactory vision, \<0=unsatisfactory vision.
Time frame: 1 and 2 weeks
Overall Corneal Staining
Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.
Time frame: after 2 weeks use
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Southern Eyes
Concord, North Carolina, United States
Western Reserve Vision Care
Beachwood, Ohio, United States
Primary Eyecare Group, P.C.
Brentwood, Tennessee, United States