Trial Outcomes & Findings for Evaluation of Acuvue Oasys 1-Day Contact Lenses in New Wearers (NCT NCT06333613)

NCT ID: NCT06333613

Last Updated: 2025-06-03

Results Overview

Slit Lamp Findings (SLFs) 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). SLF assessment was performed on each subject eye at different study visits (Baseline, unscheduled visits, 1-week follow-up, 2-Week Follow-up, and Final Evaluation). The percentage of eyes with SLF of grade 3 or grade 4 was reported.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: Up to 2-Week Follow-up
• Results posted on: 2025-06-03

Participant Flow

A total of 36 subjects were enrolled in this study. Of those enrolled, 34 subjects were dispensed the study lens, while 1 subject withdrew consent before lens dispensing and 1 subject failed to meet all eligibility criteria. Of those dispensed, 33 subjects completed the study while 1 subject was discontinued.

Participant milestones

Measure	Test (Senofilcon A C3) All eligible subjects were dispensed the study lens.
Overall Study STARTED	34
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Test (Senofilcon A C3) All eligible subjects were dispensed the study lens.
Overall Study Doesn't Like Wearing Contacts	1

Baseline Characteristics

Evaluation of Acuvue Oasys 1-Day Contact Lenses in New Wearers

Baseline characteristics by cohort

Measure	Test (Senofilcon A C3) n=34 Participants All eligible subjects were dispensed the study lens.
Age, Continuous	23.1 Years STANDARD_DEVIATION 7.59 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	34 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.

Slit Lamp Findings (SLFs) 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). SLF assessment was performed on each subject eye at different study visits (Baseline, unscheduled visits, 1-week follow-up, 2-Week Follow-up, and Final Evaluation). The percentage of eyes with SLF of grade 3 or grade 4 was reported.

Outcome measures

Measure	Test (Senofilcon A C3) n=68 Eyes All subjects that were dispensed the Test lens.
Incidence (Percentage) of Eyes With Grade 3 or 4 Slit Lamp Findings Related to the Study Lenses	0 Percentage

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: osova@its.jnj.com

Results disclosure agreements

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