This is a 30-Day, multi-site, single-masked, bilateral, active- controlled, 2-Arm parallel group study to evaluate the safety and efficacy of an Investigational product.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
121
Investigational Product
Control Product
Vue Optical Boutique
Jacksonville, Florida, United States
Stam & Associates Eye Care
Jacksonville, Florida, United States
Kannarr Eye Care
Pittsburg, Kansas, United States
Complete Eye Care of Medina
Medina, Minnesota, United States
Change in Overall Quality of Ocular Comfort From Baseline to 30-Day Follow-Up Using VAS Scores
Subjective ocular comfort was assessed at baseline, and at 30-day follow-up using a Visual Analogue Scale (VAS) with continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular comfort score was calculated as 30-day follow-up score minus baseline score. Change from baseline VAS scores range from -100 to 100, where higher change from baseline comfort scores indicates better performance. The average change from baseline comfort score for each Arm was reported.
Time frame: Baseline and 30-Day Follow-up
Change in Overall Quality of Vision From Baseline to 30-Day Follow-Up Using VAS Scores
Subjective vision was assessed at baseline, and at 30-day follow-up using a Visual Analogue Scale (VAS) with continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline quality of vision score was calculated as 30-day follow-up score minus baseline score. Change from baseline VAS scores range from -100 to 100, where higher change from baseline vision scores indicates better performance. The average change from baseline vision score for each arm was report.
Time frame: Baseline and 30-Day Follow-up
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ProCare Vision Centers
Granville, Ohio, United States
Total Eye Care
Memphis, Tennessee, United States
Tyler Eye Associates
Tyler, Texas, United States
Botetourt Eyecare, LLC
Salem, Virginia, United States