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Trial Outcomes & Findings for Clinical Evaluation of 2-Week Reusable ACUVUE 2 Vivid Style (NCT NCT03431441)

NCT ID: NCT03431441

Last Updated: 2019-03-05

Results Overview

Monocular high illuminance high contrast VA with the study lenses was collected to the nearest letter using computer generated logMAR charts. 0.02 logMAR is equivalent to 1 letter. Negative logMAR values indicate better lens performance. The average visual acuity was reported for each lens type.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

5 minutes after lens fitting

Results posted on

2019-03-05

Participant Flow

A total of 26 subjects were enrolled in the study. Of those enrolled, 24 subjects were assigned and administered. Of the total assigned subjects, 19 subjects completed the study, while 5 subjects were discontinued from the study.

Participant milestones

Participant milestones
Measure
Test
Subject that wore the etafilcon A lenses throughout the entire duration of the study.
Overall Study
STARTED
24
Overall Study
COMPLETED
19
Overall Study
NOT COMPLETED
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Test
Subject that wore the etafilcon A lenses throughout the entire duration of the study.
Overall Study
Withdrawal by Subject
2
Overall Study
Adverse Event
2
Overall Study
Dispensed Incorrect Replacement Lens
1

Baseline Characteristics

Clinical Evaluation of 2-Week Reusable ACUVUE 2 Vivid Style

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Test
n=24 Participants
Subject that wore the etafilcon A lenses throughout the entire duration of the study.
Age, Continuous
28.6 Year
STANDARD_DEVIATION 5.43 • n=5 Participants
Sex: Female, Male
Female
24 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
Race (NIH/OMB)
Asian
2 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
4 Participants
n=5 Participants
Race (NIH/OMB)
White
17 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 5 minutes after lens fitting

Population: All subjects who received at least one study article regardless of the randomization status.

Monocular high illuminance high contrast VA with the study lenses was collected to the nearest letter using computer generated logMAR charts. 0.02 logMAR is equivalent to 1 letter. Negative logMAR values indicate better lens performance. The average visual acuity was reported for each lens type.

Outcome measures

Outcome measures
Measure
Test
n=46 Eyes
Subject that wore the etafilcon A lenses throughout the entire duration of the study.
LogMAR Objective Vision (High Illumination/High Contrast)
-0.105 logMAR
Standard Deviation 0.0546

Adverse Events

Test

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

Meredith Bishop OD, MS, FAAO

Johnson & Johnson Vision Care

Phone: 904-443-1396

Results disclosure agreements

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

Restriction type: GT60