Trial Outcomes & Findings for Clinical Evaluation of Two Approved Contact Lenses (NCT NCT02759692)

A total of 283 subjects were enrolled into this study. Of the enrolled subjects all were dispensed at least one study lens. Of the dispensed subjects 276 subjects completed the study and 7 subjects were discontinued.

Clinical Evaluation of Two Approved Contact Lenses

Overall comfort 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. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.

Overall quality of vision 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. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.

Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: (\[\] indicate the question was abbreviated due to space)1."These Lenses Were Very Comfortable At The End Of The Day" 2."The Comfort of these lenses decreased throughout the day" 3. The lenses were very comfortable from the time I got up to the time I went to bed" 4. "Overall Comfort" 5. "Comfort throughout the Day"

Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: (\[\] indicate the question was abbreviated due to space)6. "Comfort at the end of the day" 7. They remained comfortable from the moment I put them in until the moment I took them out" 8."Comfort from activity to activity" 9. Comfort across different environments" 10."Comfort while working on a computer"

Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: (\[\] indicate the question was abbreviated due to space). 11."I was very satisfied with my distance vision when i first put these lenses in my eyes. 12."I was very satisfied by the clarity of my vision at the end of the day" 13."I was satisfied with the quality of my vision at night" 14."With these lenses, I felt very confident to drive at night"

Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: (\[\] indicate the question was abbreviated due to space). 15."Clarity of vision during daily activities" 16."Clarity of vision in dim or low lighting conditions" 17. "Clarity of visions when driving at night".