This study is to evaluate the safety and efficacy of a new silicone hydrogel daily disposable contact lens, kalifilcon A compared to the Bausch + Lomb Biotrue ONE day® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.
Approximately 247 participants (494 eyes) will be enrolled in at approximately 20 investigative sites in the United States (US). A minimum of 20% of the randomized participants will be of Japanese descent (for example, both maternal and paternal grandparents born in Japan).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
252
Contact lens
Contact lens
Bausch Site 8
Los Angeles, California, United States
Bausch Site 9
San Francisco, California, United States
Bausch Site 10
Torrance, California, United States
Mean logMAR Contact Lens Visual Acuity
Visual acuity (VA) will be reported as letters read correctly, and the letters read will be converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant will read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters will be recorded. A decrease in the number of correct letters indicates a decrease in visual acuity. Acuity will be averaged across visits.
Time frame: 3 months
Proportion of Participants With Slit Lamp Findings Greater Than Grade 2
During an examination of both eyes without lenses, graded slit lamp findings will be assessed for each eye using Grades 0 (none), 1 (trace), 2 (mild), 3 (moderate), and 4 (severe). Using only the non-missing observations from all visits without imputation, each eye will be classified with respect to findings greater than Grade 2 at any visit (Absent or Present). Epithelial edema, epithelial microcysts, corneal staining, limbal Injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be evaluated.
Time frame: 3 months
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Bausch Site 12
Torrance, California, United States
Bausch Site 6
Sarasota, Florida, United States
Bausch Site 16
Honolulu, Hawaii, United States
Bausch Site 4
‘Aiea, Hawaii, United States
Bausch Site 7
Pittsburg, Kansas, United States
Bausch Site 11
Bloomington, Minnesota, United States
Bausch Site 1
St Louis, Missouri, United States
...and 6 more locations