Trial Outcomes & Findings for Evaluation of Investigational Daily Disposable Multifocal Contact Lenses Produced With Different Manufacturing Processes in Myopes (NCT NCT04889625)

Last Updated: 2022-07-20

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 (HLHC) 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

81 participants

Primary outcome timeframe

1-Week Follow-up

Results posted on

2022-07-20

Participant Flow

A total of 81 subjects were enrolled in this study. Of those enrolled, 78 were dispensed at least one study lens while, 3 subjects failed to meet all eligibility criteria. Of those enrolled, 68 completed the study while 10 subjects were discontinued from the study.

Participant milestones

Participant milestones
Measure	Senofilcon A (C3) / Delefilcon A / Delefilcon A Subjects that wore the senfilcon A lens during the first period and the delefilcon A lens during the second and third period.	Delefilcon A / Senofilcon A (C3) / Senofilcon A (C3) Subjects that wore the delefilcon A lens during the first period and the senofilcon A lens during the second and third period
Period 1 STARTED	40	38
Period 1 COMPLETED	37	34
Period 1 NOT COMPLETED	3	4
Period 2 STARTED	37	34
Period 2 COMPLETED	35	33
Period 2 NOT COMPLETED	2	1
Period 3 STARTED	35	33
Period 3 COMPLETED	35	33
Period 3 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Senofilcon A (C3) / Delefilcon A / Delefilcon A Subjects that wore the senfilcon A lens during the first period and the delefilcon A lens during the second and third period.	Delefilcon A / Senofilcon A (C3) / Senofilcon A (C3) Subjects that wore the delefilcon A lens during the first period and the senofilcon A lens during the second and third period
Period 1 Subject did not meet eligibility criteria and was enrolled by error	2	1
Period 1 Subject out of window	0	1
Period 1 Wrong add power dispensed	0	1
Period 1 Discontinued due to fitting guide error	1	1
Period 2 Test article no longer available	1	0
Period 2 Incorrect lens dispensed	1	0
Period 2 Wrong add power dispensed	0	1

Baseline Characteristics

Evaluation of Investigational Daily Disposable Multifocal Contact Lenses Produced With Different Manufacturing Processes in Myopes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dispensed Subjects n=78 Participants All subjects dispensed a study lens.
Age, Continuous	49.4 years STANDARD_DEVIATION 5.96 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	16 participants n=5 Participants
Race/Ethnicity, Customized White	61 participants n=5 Participants
Region of Enrollment United States	78 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-Week Follow-up

Population: Subjects that completed all study visits without a major protocol deviation impacting a primary or secondary endpoint.

Outcome measures

Outcome measures
Measure	Senofilcon A (C3) n=66 Participants Subjects that wore the senofilcon A lens during any of the three study periods.	Delefilcon A n=66 Participants Subjects that wore the delefilcon A lens during any of the three study periods.
Visual Acuity Distance (4m)	-0.13 logMAR Standard Deviation 0.097	-0.13 logMAR Standard Deviation 0.088
Visual Acuity Intermediate (64cm)	-0.04 logMAR Standard Deviation 0.105	-0.01 logMAR Standard Deviation 0.106
Visual Acuity Near (40cm)	0.07 logMAR Standard Deviation 0.134	0.09 logMAR Standard Deviation 0.128

SECONDARY outcome

Timeframe: 1-Week Follow-up

Population: Subjects that completed all study visits without a major protocol deviation impacting a primary or secondary 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.

Outcome measures

Outcome measures
Measure	Senofilcon A (C3) n=66 Participants Subjects that wore the senofilcon A lens during any of the three study periods.	Delefilcon A n=66 Participants Subjects that wore the delefilcon A lens during any of the three study periods.
Overall Vision	59.11 units on a scale Standard Deviation 20.266	52.84 units on a scale Standard Deviation 19.457

Adverse Events

Senofilcon A (C3)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delefilcon 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 R. Karkkainen, OD, MS, FAAO

Johnson & Johnson Vision Care, Inc.

Phone: 1-904-254-0152

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60