Trial Outcomes & Findings for Design Validation of Toric Contact Lenses in Senofilcon A With a Blue-Blocking Chromophore (NCT NCT05778786)

Results Overview

Distance Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. Visual acuity is assessed 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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

188 participants

Primary outcome timeframe

1-Week Follow-up

Results posted on

2024-07-17

Participant Flow

A total of 188 subjects were enrolled in this study. All 188 enrolled subjects were dispensed at least one study lens. Of those dispensed, 179 subjects completed the study while 9 subjects were discontinued.

Participant milestones

Participant milestones
Measure	Test-senofilcon A (C3)/Control-senofilcon A (C3) Subjects in this arm were randomized to receive the Test lens during the first period of the study and the Control lens during the second period of the study.	Control-senofilcon A (C3)/ Test-senofilcon A (C3) Subjects in this arm were randomized to receive the Control lens during the first period of the study and the Test lens during the second period of the study.
Period 1 STARTED	95	93
Period 1 COMPLETED	91	90
Period 1 NOT COMPLETED	4	3
Period 2 STARTED	91	90
Period 2 COMPLETED	91	88
Period 2 NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Test-senofilcon A (C3)/Control-senofilcon A (C3) Subjects in this arm were randomized to receive the Test lens during the first period of the study and the Control lens during the second period of the study.	Control-senofilcon A (C3)/ Test-senofilcon A (C3) Subjects in this arm were randomized to receive the Control lens during the first period of the study and the Test lens during the second period of the study.
Period 1 COVID-19 Related	3	3
Period 1 Withdrew Consent during Study	1	0
Period 2 Unsatisfactory Lens Fitting due to Study Lens	0	1
Period 2 Other: Incorrect Study Lens Dispensed	0	1

Baseline Characteristics

Design Validation of Toric Contact Lenses in Senofilcon A With a Blue-Blocking Chromophore

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dispensed Subjects n=188 Participants All subjects dispensed at least one study lens.
Age, Continuous	29.3 Years STANDARD_DEVIATION 5.66 • n=5 Participants
Sex: Female, Male Female	127 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants
Race/Ethnicity, Customized White	176 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=5 Participants
Region of Enrollment United States	188 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-Week Follow-up

Population: All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.

Distance Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. Visual acuity is assessed 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.

Outcome measures

Outcome measures
Measure	Test-senofilcon A (C3) n=360 Eyes Subjects that wore the Test lens during either period 1 or period 2 of the study	Control-senofilcon A (C3) n=362 Eyes Subjects that wore the Control lens during either period 1 or period 2 of the study
Distance Monocular logMAR Visual Acuity	-0.107 logMAR Standard Deviation 0.0740	-0.104 logMAR Standard Deviation 0.0705

PRIMARY outcome

Timeframe: 1-Week Follow-up

Population: All dispensed subjects regardless of deviation from protocol with data collected at the 1-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.

Outcome measures

Outcome measures
Measure	Test-senofilcon A (C3) n=180 Participants Subjects that wore the Test lens during either period 1 or period 2 of the study	Control-senofilcon A (C3) n=181 Participants Subjects that wore the Control lens during either period 1 or period 2 of the study
CLUE Vision Score	68.75 Units on a scale Standard Deviation 21.547	70.18 Units on a scale Standard Deviation 19.912

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

Outcome measures
Measure	Test-senofilcon A (C3) n=370 Eyes Subjects that wore the Test lens during either period 1 or period 2 of the study	Control-senofilcon A (C3) n=368 Eyes Subjects that wore the Control lens during either period 1 or period 2 of the study
Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees	0.9784 Proportion of eyes	0.9918 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

Outcome measures
Measure	Test-senofilcon A (C3) n=370 Eyes Subjects that wore the Test lens during either period 1 or period 2 of the study	Control-senofilcon A (C3) n=368 Eyes Subjects that wore the Control lens during either period 1 or period 2 of the study
Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees	1 Proportion of eyes	1 Proportion of eyes

PRIMARY outcome

Timeframe: Up to 1-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 acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens.

Outcome measures

Outcome measures
Measure	Test-senofilcon A (C3) n=370 Eyes Subjects that wore the Test lens during either period 1 or period 2 of the study	Control-senofilcon A (C3) n=368 Eyes Subjects that wore the Control lens during either period 1 or period 2 of the study
Proportion of Eyes With Acceptable Lens Fitting	1 Proportion of eyes	1 Proportion of eyes

PRIMARY outcome

Timeframe: Up to 1-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 for each lens.

Outcome measures

Outcome measures
Measure	Test-senofilcon A (C3) n=370 Eyes Subjects that wore the Test lens during either period 1 or period 2 of the study	Control-senofilcon A (C3) n=368 Eyes Subjects that wore the Control lens during either period 1 or period 2 of the study
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings	0 Proportion of eyes	0 Proportion of eyes

SECONDARY outcome

Timeframe: 1-Week Follow-up

Population: All dispensed subjects regardless of deviation from protocol with data collected at the 1-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 score was reported.

Outcome measures

Outcome measures
Measure	Test-senofilcon A (C3) n=180 Participants Subjects that wore the Test lens during either period 1 or period 2 of the study	Control-senofilcon A (C3) n=181 Participants Subjects that wore the Control lens during either period 1 or period 2 of the study
CLUE Comfort Score	66.20 Units on a scale Standard Deviation 24.134	67.04 Units on a scale Standard Deviation 22.269

SECONDARY outcome

Timeframe: 1-Week Follow-up

Population: All dispensed subjects regardless of deviation from protocol with data collected at the 1-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 score was reported.

Outcome measures

Outcome measures
Measure	Test-senofilcon A (C3) n=180 Participants Subjects that wore the Test lens during either period 1 or period 2 of the study	Control-senofilcon A (C3) n=181 Participants Subjects that wore the Control lens during either period 1 or period 2 of the study
CLUE Handling Score	70.30 Units on a scale Standard Deviation 20.999	70.87 Units on a scale Standard Deviation 22.752

Adverse Events

Test-senofilcon A (C3)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control-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

Benjamin Straker

Johnson & Johnson Vision Care, Inc. (JJVC)

Phone: 1-800-843-2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60