Trial Outcomes & Findings for Clinical Evaluation of Manufacturing Processes for a Reusable Multifocal Optical Design in a Presbyopic Population (NCT NCT03787472)

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

45 participants

Primary outcome timeframe

2-Week Follow-up

Results posted on

2020-06-23

Participant Flow

A total of 45 subjects were enrolled in this study and all 45 subjects were randomly assigned to one of the two lens sequences and completed the study. 3 subjects were excluded from analysis and 42 were included in Per-Protocol Population.

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	23	22
Period 1 COMPLETED	23	22
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	23	22
Period 2 COMPLETED	23	22
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of Manufacturing Processes for a Reusable Multifocal Optical Design in a Presbyopic Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=42 Participants 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.
Age, Continuous	56.1 years STANDARD_DEVIATION 7.55 • n=93 Participants
Sex: Female, Male Female	35 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants
Race/Ethnicity, Customized Black or African American	1 participants n=93 Participants
Race/Ethnicity, Customized White	41 participants n=93 Participants
Region of Enrollment United States	42 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=42 Participants Subjects that wore the Test lens in either the first or second period of the study.	Control n=42 Participants Subjects that wore the Control lens in either the first or second period of the study.
CLUE Vision	52.77 units on a scale Standard Deviation 18.872	52.23 units on a scale Standard Deviation 19.54

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.

Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated under high luminance and high contrast conditions at three distances: Distance (3 meters) was measured using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; Intermediate (64 centimeters) and Near (40 centimeters) were measured using Reduced Guillon-Poling Charts. Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.

Outcome measures

Outcome measures
Measure	Test n=84 Eyes Subjects that wore the Test lens in either the first or second period of the study.	Control n=84 Eyes Subjects that wore the Control lens in either the first or second period of the study.
logMAR Visual Acuity Distance Standard High Contrast Bright	-0.088 logMAR units Standard Deviation 0.0885	-0.096 logMAR units Standard Deviation 0.0938
logMAR Visual Acuity Intermediate Standard High Contrast Bright	-0.047 logMAR units Standard Deviation 0.0863	-0.035 logMAR units Standard Deviation 0.0950
logMAR Visual Acuity Near Standard High Contrast Bright	0.080 logMAR units Standard Deviation 0.0908	0.076 logMAR units Standard Deviation 0.0903

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