Trial Outcomes & Findings for Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes (NCT NCT02394925)

Last Updated: 2018-06-19

Results Overview

Proportion of Successful contact lens wearers is based on a subject's responses to two questionnaire items, "Overall Quality of Vision" and "Overall Comfort". Each item uses a 6 response like-rt scale (0= Not Applicable, 1=Excellent, 2=Very Good, 3=Good, 4=Fair and 5=Poor). The data from each item was dichotomized into two groups. If a subject responded "Excellent", "Very Good" or "Good" then the response=1, otherwise the response=0. The proportion of subjects with response=1 was reported as the proportion of successful contact lens wearers.

Recruitment status

COMPLETED

Study phase

Target enrollment

113 participants

Primary outcome timeframe

2 months post wear

Results posted on

2018-06-19

Participant Flow

A total of 113 enrolled into this study. Of the enrolled, 5 subjects did not meet the eligibility criteria and 108 subjects were dispensed the study lens. Of the dispensed subjects 79 completed the study while 29 subjects were discontinued.

Participant milestones

Participant milestones
Measure	Etafilcon -PVP (Multi-focal) All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study.
Overall Study STARTED	108
Overall Study COMPLETED	79
Overall Study NOT COMPLETED	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Etafilcon -PVP (Multi-focal) All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study.
Overall Study Adverse Event	1
Overall Study Lens Discomfort	3
Overall Study Lens handling difficulities	5
Overall Study Lost to Follow-up	9
Overall Study Protocol Violation	5
Overall Study No longer meet eligibility criteria	1
Overall Study Unsatisfactory Visual Response	5

Baseline Characteristics

Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dispensed Subjects n=108 Participants All subjects in that were dispensed the study lens.
Age, Continuous	49.9 years STANDARD_DEVIATION 6.13 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	31 Participants n=5 Participants
Race (NIH/OMB) White	73 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants
Region of Enrollment United Kingdom	62 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months post wear

Population: Subjects that completed all study visits without a major protocol deviation.

Outcome measures

Outcome measures
Measure	Etafilcon -PVP (Multi-focal) n=78 Participants All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study.
Proportion of Successful Contact Lens Wearers	0.71 Proportion of Subjects

Adverse Events

Etafilcon -PVP (Multi-focal)

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

Thomas R. Karkkainen, OD, MS, FAAO Sr. Principal Research Optometrist

Johnson & Johnson Vision Care Inc.

Phone: 904 443-3402

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60