Trial Outcomes & Findings for Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses (NCT NCT06377488)

NCT ID: NCT06377488

Last Updated: 2025-10-28

Results Overview

Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling 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. Data from hyperopes and myopes were combined for this outcome since logMAR scores between the two populations are similar.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 176 participants
• Primary outcome timeframe: 2-Week Follow-up
• Results posted on: 2025-10-28

Participant Flow

A total of 176 subjects were enrolled in this study. Of those enrolled, 171 subjects were dispensed the study lens, while 5 subjects failed to meet all eligibility criteria. Of those dispensed, 163 subjects completed the study while 8 subjects were discontinued.

Participant milestones

Measure	Test (Senofilcon A C3) Subject that wore the Test lens at any point during the study.
Overall Study STARTED	171
Overall Study COMPLETED	163
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Test (Senofilcon A C3) Subject that wore the Test lens at any point during the study.
Overall Study Unsatisfactory Visual Response due to Test Article	2
Overall Study Unsatisfactory Lens Fitting due to Test Article	2
Overall Study Protocol Violation	1
Overall Study Lost to Follow-up	1
Overall Study Incorrect Lens Dispensed	2

Baseline Characteristics

Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses

Baseline characteristics by cohort

Measure	Myopes n=105 Participants Subjects were classified as Myopic if the distance spherical equivalent refraction was in the range of -1.25 D to -3.75 D.	Hyperopes n=66 Participants Subjects were classified as Hyperopic if the distance spherical equivalent refraction was in the range of +1.25 D to +4.25 D.	Total n=171 Participants Total of all reporting groups
Age, Continuous	49.9 Years STANDARD_DEVIATION 6.89 • n=5 Participants	59.1 Years STANDARD_DEVIATION 6.10 • n=7 Participants	53.5 Years STANDARD_DEVIATION 7.97 • n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	51 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	15 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	93 Participants n=5 Participants	62 Participants n=7 Participants	155 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	105 Participants n=5 Participants	66 Participants n=7 Participants	171 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2-Week Follow-up

Population: All dispensed subjects regardless of deviation from protocol with data collected at the 2-week follow-up.

Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling 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. Data from hyperopes and myopes were combined for this outcome since logMAR scores between the two populations are similar.

Outcome measures

Measure	Test (Senofilcon A C3) n=163 Participants Subject that wore the Test lens at any point during the study.
HLHC Binocular logMAR Visual Acuities Distance (4m)	-0.088 logMAR Standard Deviation 0.0874
HLHC Binocular logMAR Visual Acuities Intermediate (64cm)	-0.018 logMAR Standard Deviation 0.1106
HLHC Binocular logMAR Visual Acuities Near (40cm)	0.087 logMAR Standard Deviation 0.1103

PRIMARY outcome

Timeframe: 2-Week Follow-up

Population: All dispensed subjects regardless of deviation from protocol with data collected at the 2-week follow-up.

Subjective 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. The average CLUE vision score for each sphere stratum (Hyperope and Myope) was reported.

Outcome measures

Measure	Test (Senofilcon A C3) n=164 Participants Subject that wore the Test lens at any point during the study.
CLUE Vision Scores Myopes	61.13 Units on a Scale Standard Deviation 21.181
CLUE Vision Scores Hyperopes	56.19 Units on a Scale Standard Deviation 18.634

PRIMARY outcome

Timeframe: 15-minutes after lens insertion

Population: All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.

Absolute rotation was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens.

Outcome measures

Measure	Test (Senofilcon A C3) n=171 Participants Subject that wore the Test lens at any point during the study.
Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees	0.9474 Proportion of eyes

PRIMARY outcome

Timeframe: 15-minutes after lens insertion

Population: All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.

Rotational Stability was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Rotational Stability was dichotomized into a binary response where Y=1 if Rotational Stability was less than or equal to 5 degrees and Y=0 otherwise (Rotational Stability greater than 5 degrees). The proportion of eyes with Rotational Stability less than or equal to 5 degrees was report for each lens.

Outcome measures

Measure	Test (Senofilcon A C3) n=342 Eyes Subject that wore the Test lens at any point during the study.
Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees	1 Proportion of eyes

PRIMARY outcome

Timeframe: Up to 2-Week Follow-up

Population: All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.

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 and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported. Data from the hyperope and myopes group were combined for this outcome since the rate of SFLs grade 3+ is similar for these two populations.

Outcome measures

Measure	Test (Senofilcon A C3) n=342 Eyes Subject that wore the Test lens at any point during the study.
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings	0.0029 Proportion of eyes

PRIMARY outcome

Timeframe: Up to 2-Week Follow-up

Population: All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.

Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion at the 1-week follow-up.

Lens fit was a binary variable where unacceptable lens fit=1 and acceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. Data from the hyperope and myopes group were combined for this outcome since lens fitting characteristics are similar for these two populations.

Outcome measures

Measure	Test (Senofilcon A C3) n=342 Eyes Subject that wore the Test lens at any point during the study.
Proportion of Eyes With Unacceptable Lens Fitting	0 Proportion of eyes

SECONDARY outcome

Timeframe: 2-Week Follow-up

Population: All dispensed subjects regardless of deviation from protocol with data collected at the 2-week follow-up.

Subjective 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. The average CLUE vision score for each sphere stratum (Hyperope and Myope) was reported.

Outcome measures

Measure	Test (Senofilcon A C3) n=164 Participants Subject that wore the Test lens at any point during the study.
CLUE Vision Scores Myopes	61.13 Units on a Scale Standard Deviation 21.181
CLUE Vision Scores Hyperopes	56.19 Units on a Scale Standard Deviation 18.634

SECONDARY outcome

Timeframe: 2-Week Follow-up

Population: All dispensed subjects regardless of deviation from protocol with data collected at the 2-week follow-up.

Subjective 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. The average CLUE comfort scores for each sphere stratum (Hyperope and Myope) were reported.

Outcome measures

Measure	Test (Senofilcon A C3) n=164 Participants Subject that wore the Test lens at any point during the study.
CLUE Comfort Scores Myopes	63.63 Units on a Scale Standard Deviation 22.498
CLUE Comfort Scores Hyperopes	62.56 Units on a Scale Standard Deviation 20.732

SECONDARY outcome

Timeframe: 2-Week Follow-up

Population: All dispensed subjects regardless of deviation from protocol with data collected at the 2-week follow-up.

Subjective handling 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 handling scores for each sphere stratum (Hyperope and Myope) were reported.

Outcome measures

Measure	Test (Senofilcon A C3) n=164 Participants Subject that wore the Test lens at any point during the study.
CLUE Handling Scores Myopes	68.03 Units on a Scale Standard Deviation 19.455
CLUE Handling Scores Hyperopes	67.88 Units on a Scale Standard Deviation 20.677

SECONDARY outcome

Timeframe: Up to 1-Week Follow-up

Population: All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.

The number of lenses to achieve the optimal pair for each subject was calculated as the original pair (2) plus all the required modifications to reach the optimal pair. In this study the minimum number of lenses per subject used was 2 where the maximum possible number of lenses used was 10. The data was dichotomized as Y=1 if the subject was able to achieve optimal lens pair in 4 lenses or lenses or less and 0 otherwise. A lens modification was performed if the subject reports unsatisfactory vision or was unable to obtain 20/30 distance visual acuity in both eyes. If the subject reported satisfactory vision with the lenses a modification was not required. However, based upon the investigator's findings on the measured visual acuity and/or over- refraction a modification may have been performed. Data for the hyperope and myope groups were combined for this endpoint since the number of subjects needed to optimize vision is independent of which group a subject belongs to.

Outcome measures

Measure	Test (Senofilcon A C3) n=171 Participants Subject that wore the Test lens at any point during the study.
Proportion of Subject Achieving Optimal Lens Pair in 4 Lenses or Less.	0.971 Proportion of Subjects

Adverse Events

Test (Senofilcon A C3)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Johnson & Johnson Vision Care Study Contact

Johnson & Johnson Vision Care

Phone: 1-800-843-2020

Email: RFrankl1@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place