Trial Outcomes & Findings for Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over Two Weeks of Wear (NCT NCT06161012)

Results Overview

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, 2-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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

67 participants

Primary outcome timeframe

Up to 2-Week Follow-up

Results posted on

2025-06-22

Participant Flow

A total of 67 subjects were enrolled in this study. Of those enrolled, all 67 subjects were dispensed at least one study lens. Of those dispensed, 66 subjects completed the study while one subject was discontinued.

Participant milestones

Participant milestones
Measure	Delefilcon A/ Senofilcon A (C3) Subjects in this sequence were randomized to receive the delefilcon A lens during the first period and the senofilcon A (C3) lens during the second period	Senofilcon A (C3)\Delefilcon A Subjects in this sequence were randomized to receive the senofilcon A (C3) lens during the first period and the delefilcon A lens during the second period
Period 1 STARTED	33	34
Period 1 COMPLETED	32	34
Period 1 NOT COMPLETED	1	0
Period 2 STARTED	32	34
Period 2 COMPLETED	32	34
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Delefilcon A/ Senofilcon A (C3) Subjects in this sequence were randomized to receive the delefilcon A lens during the first period and the senofilcon A (C3) lens during the second period	Senofilcon A (C3)\Delefilcon A Subjects in this sequence were randomized to receive the senofilcon A (C3) lens during the first period and the delefilcon A lens during the second period
Period 1 Unsatisfactory Lens Fitting due to Test Article	1	0

Baseline Characteristics

Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over Two Weeks of Wear

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=67 Participants Subjects dispensed at least one study lens.
Age, Continuous	29.1 Years STANDARD_DEVIATION 5.35 • n=93 Participants
Sex: Female, Male Female	45 Participants n=93 Participants
Sex: Female, Male Male	22 Participants n=93 Participants
Race/Ethnicity, Customized Asian	1 Participants n=93 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=93 Participants
Race/Ethnicity, Customized White	61 Participants n=93 Participants
Race/Ethnicity, Customized Multiple	2 Participants n=93 Participants

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, 2-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	Senofilcon A (C3) n=132 Eyes Subjects that wore the senofilcon A (C3) lens during either the first or second study periods.	Delefilcon A n=132 Eyes Subjects that wore the delefilcon A lens during either the first or second study periods.
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings	0 Proportion of Eyes	0 Proportion of Eyes

Adverse Events

Senofilcon A (C3)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delefilcon A

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

David Murakami, OD, MPH, FAAO

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