Trial Outcomes & Findings for Clinical Performance of Two Daily Disposable Silicone Hydrogel Contact Lenses (NCT NCT05554640)

Results Overview

Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion, the 1- and 2-week follow-up evaluations and any unscheduled visits. 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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

Up to 2-Week Follow-up

Results posted on

2023-12-20

Participant Flow

A total of 16 subjects were enrolled in this study. Of those enrolled, 14 subjects were dispensed at least one study lens, while 2 subjects failed to meet all eligibility criteria. All dispensed subjects completed the study.

Participant milestones

Participant milestones
Measure	Delefilcon A / Senofilcon A Subjects randomized to receive the delefilcon A lens during period 1 and the senofilcon A lens during period 2.	Senofilcon A / Delefilcon A Subjects randomized to receive the senofilcon A lens during period 1 and the delefilcon A lens during period 2.
Period 1 STARTED	7	7
Period 1 COMPLETED	7	7
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	7	7
Period 2 COMPLETED	7	7
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Performance of Two Daily Disposable Silicone Hydrogel Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dispensed Subjects n=14 Participants All subjects dispensed a study lens.
Age, Continuous	31.1 Years STANDARD_DEVIATION 6.73 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants
Race/Ethnicity, Customized White	9 Participants n=5 Participants
Region of Enrollment United Kingdom	14 Participants n=5 Participants

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, the 1- and 2-week follow-up evaluations and any unscheduled visits. 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.

Outcome measures

Outcome measures
Measure	Delefilcon A n=28 Eyes Subjects that wore the delefilcon A lens during either the first or second period of the study.	Senofilcon A n=28 Eyes Subjects that wore the senofilcon A lens in either the first or second period of the study.
Proportion of Eyes With Acceptable Lens Fitting	100 Proportion of eyes	100 Proportion of eyes

Adverse Events

Delefilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Senofilcon 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

John R. Buch, O.D., M.S.

Johnson & Johnson Vision Care (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