Trial Outcomes & Findings for Evaluation of Two Marketed Multifocal Contact Lenses (NCT NCT03322423)

Results Overview

Distance visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

78 participants

Primary outcome timeframe

1-Week Follow-up

Results posted on

2019-01-08

Participant Flow

A total of 78 subjects were enrolled into this study. Of the enrolled all 78 were dispensed at least one study lens. Of the dispensed subjects 71 completed the study, while 7 subjects were discontinued.

Participant milestones

Participant milestones
Measure	Delefilcon A/Nesofilcon A All subjects that were randomized to receive the delefilcon A lens during the first period of the study and the nesofilcon A lens during the second period of the study.	Nesofilcon A/Delefilcon A All subjects that were randomized to receive the nesofilcon A during the first period of the study and the delefilcon A lens during the second period of the study.
Period 1 STARTED	38	40
Period 1 COMPLETED	36	38
Period 1 NOT COMPLETED	2	2
Period 2 STARTED	36	38
Period 2 COMPLETED	35	36
Period 2 NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Delefilcon A/Nesofilcon A All subjects that were randomized to receive the delefilcon A lens during the first period of the study and the nesofilcon A lens during the second period of the study.	Nesofilcon A/Delefilcon A All subjects that were randomized to receive the nesofilcon A during the first period of the study and the delefilcon A lens during the second period of the study.
Period 1 Subject no longer eligible	0	1
Period 1 Withdrawal by Subject	0	1
Period 1 Incorrect Lens Dispensed	1	0
Period 1 Unsatisfactory Lens Fitting	1	0
Period 2 Dispensed incorrect lens in left eye	0	1
Period 2 Protocol Violation	1	0
Period 2 Subject not eligible for Pytergiumectomy	0	1

Baseline Characteristics

Evaluation of Two Marketed Multifocal Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Dispensed Subjects n=78 Participants All subjects that were dispensed a study lens.
Age, Continuous	53.9 Years STANDARD_DEVIATION 7.27 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants
Race/Ethnicity, Customized White	73 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants
Region of Enrollment United States	78 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-Week Follow-up

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

Distance visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts.

Outcome measures

Outcome measures
Measure	Delefilcon A n=110 Eyes All subjects that wore the delefilcon A lens during either the first or second period of the study.	Nesofilcon A n=110 Eyes All subjects that wore the nesofilcon A lens during either the first or second period of the study.
Distance Binocular Visual Acuity	-0.056 logMAR Standard Deviation 0.0842	-0.075 logMAR Standard Deviation 0.0759

PRIMARY outcome

Timeframe: 1-Week Follow-up

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

Near visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using reduced Guillon-Poling Charts.

Outcome measures

Outcome measures
Measure	Delefilcon A n=110 Eyes All subjects that wore the delefilcon A lens during either the first or second period of the study.	Nesofilcon A n=110 Eyes All subjects that wore the nesofilcon A lens during either the first or second period of the study.
Near Binocular Visual Acuity	0.143 logMAR Standard Deviation 0.1084	0.143 logMAR Standard Deviation 0.1117

SECONDARY outcome

Timeframe: 1-Week Follow-up

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

Overall quality of 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	Delefilcon A n=65 Participants All subjects that wore the delefilcon A lens during either the first or second period of the study.	Nesofilcon A n=65 Participants All subjects that wore the nesofilcon A lens during either the first or second period of the study.
Overall Quality of Vision	47.4 Units on a scale Standard Deviation 17.81	49.3 Units on a scale Standard Deviation 19.43

Adverse Events

Delefilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nesofilcon 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

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

Johnson & Johnson Vision Care Inc.

Phone: 1-904-443-3402

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60