Trial Outcomes & Findings for Clinical Evaluation of Investigational Multifocal Contact Lenses (NCT NCT03059810)

Results Overview

Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

72 participants

Primary outcome timeframe

12-16 Day Follow-up

Results posted on

2019-12-24

Participant Flow

A total of 72 subjects were enrolled into this study. Of the enrolled subjects 63 were dispensed at least one study lens and 9 did not meet the eligibility criteria. All 63 dispensed subjects completed the study.

Participant milestones

Participant milestones
Measure	Etafilcon A With PVP All subject wore the etafilcon A with PVP lens throughout the entire duration of the study.
Overall Study STARTED	63
Overall Study COMPLETED	63
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of Investigational Multifocal Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etafilcon A With PVP n=63 Participants All subject wore the etafilcon A with PVP lens throughout the entire duration of the study.
Age, Continuous	56.5 Years STANDARD_DEVIATION 6.65 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants
Race/Ethnicity, Customized White	61 Participants n=5 Participants
Region of Enrollment United States	63 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12-16 Day Follow-up

Population: Subjects that completed all visits without a major protocol deviation documented as impacted the assessment of the primary endpoint.

Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

Outcome measures

Outcome measures
Measure	Etafilcon A With PVP n=62 Participants All subject wore the etafilcon A with PVP lens throughout the entire duration of the study.
Overall Vision	47.33 Units on a Scale Standard Deviation 18.646

Adverse Events

Etafilcon A With PVP

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 Karkkainen- SR PRINCIPAL RESEARCH OPTOMETRIST

Johnson & Johnson Vision

Phone: 904 443-3402

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60