Trial Outcomes & Findings for Clinical Evaluation of Delefilcon A and Verofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of Wear (NCT NCT05502289)

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), however data collected at the 1-week follow-up is the primary endpoint. The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The percentage of eyes with SLF with grade 3 or higher was reported for each lens type.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

1-Week Follow-up

Results posted on

2023-11-07

Participant Flow

A total of 66 subjects were enrolled in this study. Of those enrolled, all 66 subjects were dispensed at least one study lens. Of those dispensed, 65 subjects completed the study while 1 subject was discontinued.

Participant milestones

Participant milestones
Measure	Test (DT1fA) \ Control (P1fA) Subjects randomized to this sequence received the Test (DT1fA) lens during the first period and then received the Control (P1fA) lens during the second period	Control (P1fA) \ Test (DT1fA) Subjects randomized to this sequence received the Control (P1fA) lens during the first period and then received the Test (DT1fA) lens during the second period
Period 1 STARTED	35	31
Period 1 COMPLETED	34	31
Period 1 NOT COMPLETED	1	0
Period 2 STARTED	34	31
Period 2 COMPLETED	34	31
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Test (DT1fA) \ Control (P1fA) Subjects randomized to this sequence received the Test (DT1fA) lens during the first period and then received the Control (P1fA) lens during the second period	Control (P1fA) \ Test (DT1fA) Subjects randomized to this sequence received the Control (P1fA) lens during the first period and then received the Test (DT1fA) lens during the second period
Period 1 Out Of Window	1	0

Baseline Characteristics

Clinical Evaluation of Delefilcon A and Verofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of Wear

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dispensed Subjects n=66 Participants All subjects dispensed at least one study lens.
Age, Continuous	30.2 Years STANDARD_DEVIATION 5.56 • n=93 Participants
Sex: Female, Male Female	40 Participants n=93 Participants
Sex: Female, Male Male	26 Participants n=93 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=93 Participants
Race/Ethnicity, Customized White	61 Participants n=93 Participants
Region of Enrollment United States	66 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1-Week Follow-up

Population: All subjects who were administered at least one study lens and had at least one observation recorded.

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), however data collected at the 1-week follow-up is the primary endpoint. The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The percentage of eyes with SLF with grade 3 or higher was reported for each lens type.

Outcome measures

Outcome measures
Measure	Test (DT1fA) n=132 Eyes Subjects that wore the Test (DT1fA) lens in either the first or second period of the study.	Control (P1fA) n=132 Eyes Subjects that wore the Control (P1fA) lens in either the first or second period of the study.
Percentage of Eyes With Grade 3 or Higher Slit Lamp Findings	0 Percent	0 Percent

Adverse Events

Test (DT1fA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control (P1fA)

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) 7500 Centurion

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