Trial Outcomes & Findings for Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population (NCT NCT03581825)

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

63 participants

Primary outcome timeframe

2-Week Follow-up

Results posted on

2020-05-08

Participant Flow

A total of 63 subjects were enrolled in this study. Of those, 62 were dispensed at least 1 study lens. Of those dispensed a study lens, 60 subjects completed the study while 2 were discontinued from the study.

Participant milestones

Participant milestones
Measure	Test/Control Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period	Control/Test Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period
Period 1 STARTED	31	31
Period 1 COMPLETED	30	31
Period 1 NOT COMPLETED	1	0
Period 2 STARTED	30	31
Period 2 COMPLETED	30	30
Period 2 NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Test/Control Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period	Control/Test Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period
Period 1 Lens Discomfort	1	0
Period 2 Unsatisfactory Vision to Test	0	1

Baseline Characteristics

Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=62 Participants All subjects dispensed a study lens
Age, Continuous	50.8 years STANDARD_DEVIATION 6.62 • n=93 Participants
Sex: Female, Male Female	50 Participants n=93 Participants
Sex: Female, Male Male	12 Participants n=93 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=93 Participants
Race/Ethnicity, Customized White	59 Participants n=93 Participants
Region of Enrollment United States	62 Participants n=93 Participants

PRIMARY outcome

Timeframe: 2-Week Follow-up

Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

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	Test n=53 Participants Subjects that wore the Test lens in either the first or second period of the study.	Control Subjects that wore the Control lens in either the first or second period of the study.
CLUE Vision	57.1 units on a scale Standard Deviation 19.16	—

SECONDARY outcome

Timeframe: 2-Week Follow-up

Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

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	Test n=53 Participants Subjects that wore the Test lens in either the first or second period of the study.	Control n=53 Participants Subjects that wore the Control lens in either the first or second period of the study.
CLUE Vision Comparison Between Test and Control	57.1 units on a scale Standard Deviation 19.16	53.3 units on a scale Standard Deviation 18.55

Adverse Events

Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Phone: 904-443-3402

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60