Non-randomized, single-masked, 2-visit, bilateral wear, single-arm dispensing study to evaluate the visual acuity, rotational performance, lens fit, stability and subjective characteristics of a senofilcon-based JJVCI investigational toric contact lens design.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
177
Investigational prototype
Edward S. Wygonik, OD
Jacksonville, Florida, United States
The Eye Center
Pembroke Pines, Florida, United States
Eye Associates of Winter Park
Winter Park, Florida, United States
Proportion of Eyes With Monocular Visual Acuity Better Than 20/40
Monocular visual acuity was assessed using distance Snellen visual acuity. Visual Acuity data was dichotomized such that 'response=1' if a subjects has 20/40 or better and 'response=0' if subject has worse than 20/40. The proportion of eyes with 20/40 or better was reported.
Time frame: 7 day follow-up
The Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees
Absolute rotation was measured using a slit lamp. Absolute rotation measured at 15-minute post insertion was categorized into a binary outcome as 'response=1' if the absolute rotation is less than or equal to 10 degrees or 'response=0' otherwise. The proportion of eyes with absolute rotation less than or equal to 10 degrees was reported.
Time frame: 15 Minutes Post Insertion
Proportion of Subjects Eyes With Lens Stability With Blink Within 5 Degrees
Lens stability with blink was measured using a slit lamp. The rotational stability of the lens during a series of normal (unforced) blinks was measured for both eyes. The data was dichotomized as 'response=1' if the lens stability was less than or equal to 5 degrees or 'response=0' otherwise. The proportion of eyes with rotational stability of 5 degrees or lower was reported.
Time frame: 15 Minutes Post Insertion
Proportion of Subject Eyes With Acceptable Lens Fit
Acceptability of contact lens fit was assessed via slit lamp and was reported as a binary response as Acceptable or Unacceptable. The proportion of eyes with acceptable fit was reported.
Time frame: 15 Minute Post Insertion
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