Trial Outcomes & Findings for Evaluation of Senofilcon A With New UV-blocker on a Neophyte Population (NCT NCT03742271)

Last Updated: 2020-03-13

Results Overview

Acceptable fit is determined by the eye care practitioner (ECP/investigator) and includes the following criteria; (1) physiological responses (No Grade 3 or higher slit lamp findings), (2) mechanical lens fitting (no unacceptable lens fitting in either eye), (3) subjects' assessment of comfort, vision and handling.

Recruitment status

COMPLETED

Study phase

Target enrollment

130 participants

Primary outcome timeframe

4-Week Follow-up

Results posted on

2020-03-13

Participant Flow

A total of 129 subjects were enrolled in this study. Of those enrolled, 127 subjects were assigned and dispensed the Test lens while, 2 subjects failed to meet all eligibility criteria. Of those dispensed, 115 subjects completed the study while, 12 subjects were discontinued from the study.

Participant milestones

Participant milestones
Measure	Senofilcon A All subjects wore the senofilcon A lens for the first 4-Weeks of the study and then wore their Habitual spectacles for a period of 1-Week after the 4-Weeks of lens wear.
Overall Study STARTED	127
Overall Study COMPLETED	115
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Senofilcon A All subjects wore the senofilcon A lens for the first 4-Weeks of the study and then wore their Habitual spectacles for a period of 1-Week after the 4-Weeks of lens wear.
Overall Study Unsatisfactory Visual Response	1
Overall Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	4
Overall Study Failed Insertion & removal	3
Overall Study Protocol Violation	1

Baseline Characteristics

Evaluation of Senofilcon A With New UV-blocker on a Neophyte Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Dispensed Subjects n=127 Participants All subjects dispensed the senofilcon A lens during any point in the study.
Age, Continuous	25.3 Years STANDARD_DEVIATION 5.79 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Count of Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Count of Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	16 Count of Participants n=5 Participants
Race/Ethnicity, Customized White	101 Count of Participants n=5 Participants
Race/Ethnicity, Customized Other	5 Count of Participants n=5 Participants
Region of Enrollment United States	127 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4-Week Follow-up

Population: All subjects who were administered a Test lens and completed through the 4-week evaluation in which the eye care practitioner completed the lens fitting assessment.

Outcome measures

Outcome measures
Measure	Senofilcon A n=114 Participants All subjects in this study wore the senofilcon A lens in both eyes through the 4-Week follow-up evaluation
Acceptable Lens Fitting	0.974 Proportion of subjects

Adverse Events

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 Buch OD F.A.A.O- Sr. Principal Research Optometrist

Johnson & Johnson Vision Care Inc.

Phone: +1 904 443-1707

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60