Trial Outcomes & Findings for Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population; Part 2 (NCT NCT04615507)

Last Updated: 2022-04-01

Results Overview

Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters), intermediate (64 centimeters) and near (40 centimeters) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be between 7.3 and 7.9 EV (394-597 lux). For Distance (4 meters), the acceptable range for the chart luminance was 10.5-10.7 EV (181 208 cd/m2). For Intermediate (64cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

71 participants

Primary outcome timeframe

1-Week Follow-up within each wearing period

Results posted on

2022-04-01

Participant Flow

A total of 71 subject were enrolled into this study. Of those enrolled, 68 were dispensed at least one study lens while 3 subjects failed to meet all eligibility criteria. Of those dispensed, 60 completed the study while 8 subjects were discontinued.

Participant milestones

Participant milestones
Measure	Test/Control/Control Subjects that wore the Test lens in a bilateral fashion during period 1 and the Control lens during both the second and third study periods.	Control/Test/Test Subjects that wore the Control lens in a bilateral fashion during period 1 and the Test lens during the second and third study periods.
Period 1 STARTED	34	34
Period 1 COMPLETED	32	33
Period 1 NOT COMPLETED	2	1
Period 2 STARTED	32	33
Period 2 COMPLETED	30	31
Period 2 NOT COMPLETED	2	2
Period 3 STARTED	30	31
Period 3 COMPLETED	30	30
Period 3 NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Test/Control/Control Subjects that wore the Test lens in a bilateral fashion during period 1 and the Control lens during both the second and third study periods.	Control/Test/Test Subjects that wore the Control lens in a bilateral fashion during period 1 and the Test lens during the second and third study periods.
Period 1 Covid-19 exposure	2	1
Period 2 Covid-19 exposure	0	1
Period 2 Protocol Violation	1	0
Period 2 Withdrawal by Subject	1	0
Period 2 Adverse Event	0	1
Period 3 Covid-19 exposure	0	1

Baseline Characteristics

Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population; Part 2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test/Control/Control n=34 Participants Subjects that wore the Test lens in a bilateral fashion during period 1 and the Control lens during both the second and third study periods.	Control/Test/Test n=34 Participants Subjects that wore the Control lens in a bilateral fashion during period 1 and the Test lens during the second and third study periods.	Total n=68 Participants Total of all reporting groups
Age, Continuous Age	49.0 Years STANDARD_DEVIATION 4.72 • n=5 Participants	52.0 Years STANDARD_DEVIATION 7.44 • n=7 Participants	50.5 Years STANDARD_DEVIATION 6.36 • n=5 Participants
Sex: Female, Male Sex · Female	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Sex · Male	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized White	33 participants n=5 Participants	31 participants n=7 Participants	64 participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	34 participants n=7 Participants	68 participants n=5 Participants

PRIMARY outcome

Timeframe: 1-Week Follow-up within each wearing period

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

Outcome measures

Outcome measures
Measure	Test n=90 Observations All subjects that wore the Test lens during any of the 3 study periods.	Control n=90 Observations All subjects that wore the Control lens during any of the 3 study periods.
Visual Performance LogMAR Distance (4m)	-0.12 logMAR Standard Deviation 0.108	-0.13 logMAR Standard Deviation 0.088
Visual Performance LogMAR Intermediate (64cm)	-0.06 logMAR Standard Deviation 0.089	-0.04 logMAR Standard Deviation 0.106
Visual Performance LogMAR Near (40cm)	0.08 logMAR Standard Deviation 0.140	0.10 logMAR Standard Deviation 0.136

SECONDARY outcome

Timeframe: 1-Week Follow-up within each wearing period

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

Overall vision scores were 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. The average CLUE vision score for each leans type was reported.

Outcome measures

Outcome measures
Measure	Test n=90 Observations All subjects that wore the Test lens during any of the 3 study periods.	Control n=90 Observations All subjects that wore the Control lens during any of the 3 study periods.
Vision Scores	59.72 units on a scale Standard Deviation 18.310	53.98 units on a scale Standard Deviation 15.108

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 Karkkainen- Sr. Research Principal Optometrist

Johnson & Johns Vision Care Inc.

Phone: 1-800-843-2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60