Validation of Senofilcon A With New UV / HEV Filter

Overall quality of vision score was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE vision score for each lens type was reported.

Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale and was evaluated at distance (4 meter) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.

Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits, 2-week follow-up and final evaluation). The data was then dichotomized into two groups. Those with Grade 3 or higher SLF and those with Grade 2 or lower. The proportion of eyes with Grade 3 or higher SLF was reported.

Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. Summaries presented in the Participant flow are summarized by planned arm, where as summaries for this measure are summarized by actual arm. One subject was dispensed the incorrect study lens, there for, the number of subjects that were randomized to the Control were 149 but 150 subjects were actually dispensed the control.

Overall comfort scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE comfort score for each lens type was reported.

Overall handling scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE handling score for each lens type was reported.

Indoor performance was assessed using the individual questionnaire item "Clarity of Vision indoors in bright light" with a 5-point Likert scale (1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor) and a Not Applicable response option. Subject responses were reported by lens using frequencies.

Situational visual performance related to digital device use was assessed using the individual preference item "Overall preference while using computer screens & digital devices". The response set include: Strongly prefer my habitual lenses, Slightly prefer my habitual lenses, No Preference, Slightly prefer the study lenses and Strongly prefer the study lenses. Responses were collapsed into three categories for analysis purpose: Prefer Study Lens, No Preference, Prefer Habitual Lens. Subject responses were reported by lens using frequencies.