Trial Outcomes & Findings for Evaluation of Investigational Daily Disposable Multifocal Contact Lenses Produced With Different Manufacturing Processes (NCT NCT04794751)

Last Updated: 2022-06-21

Results Overview

Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 m), intermediate (64 cm) and near (40 cm) under high luminance high contrast lighting conditions 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 m), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64cm) and Near (40cm), the cceptable 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. The average score was reported for each lens.

Recruitment status

COMPLETED

Study phase

Target enrollment

78 participants

Primary outcome timeframe

1-Week Follow-up

Results posted on

2022-06-21

Participant Flow

In total, 78 subject were enrolled in this study. Of those enrolled, 75 subjects were dispensed at least one study lens while 3 subjects failed to meet all eligibility criteria. Of those who were assigned and administered a test article, 64 subjects completed the study while 11 subjects were discontinued.

Participant milestones

Participant milestones
Measure	Delefilcon A/Senofilcon A C3/Senofilcon A C3 Subjects randomized to this sequence received the delefilcon A lens during the first period and then received the senofilcon A C3 lenses during the second and third periods.	Senofilcon A C3/Delefilcon A/Delefilcon A Subjects randomized to this sequence received the senofilcon A C3 lens during the first period and then received the delefilcon A lenses during the second and third periods.
Period 1 STARTED	38	37
Period 1 COMPLETED	36	32
Period 1 NOT COMPLETED	2	5
Period 2 STARTED	36	32
Period 2 COMPLETED	35	29
Period 2 NOT COMPLETED	1	3
Period 3 STARTED	35	29
Period 3 COMPLETED	35	29
Period 3 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Delefilcon A/Senofilcon A C3/Senofilcon A C3 Subjects randomized to this sequence received the delefilcon A lens during the first period and then received the senofilcon A C3 lenses during the second and third periods.	Senofilcon A C3/Delefilcon A/Delefilcon A Subjects randomized to this sequence received the senofilcon A C3 lens during the first period and then received the delefilcon A lenses during the second and third periods.
Period 1 incorrect fitting guide was used to fit subject	2	1
Period 1 Subject no longer meets eligibility criteria	0	1
Period 1 Protocol Violation	0	2
Period 1 Withdrawal by Subject	0	1
Period 2 Withdrawal by Subject	0	1
Period 2 incorrect fitting guide was used to fit subject	0	2
Period 2 Protocol Violation	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dispensed Subjects n=75 Participants All subjects dispensed a study lens.
Age, Continuous	57.5 years STANDARD_DEVIATION 6.44 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	4 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 participants n=5 Participants
Race/Ethnicity, Customized White	69 participants n=5 Participants
Region of Enrollment United States	75 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=64 Participants Subjects that wore the Test lens in either of the three study periods.	Delefilcon A n=64 Participants Subjects that wore the Control lens in either of the three study periods.
Visual Performance (logMAR) Distance (4m)	-0.08 logMAR Standard Deviation 0.068	-0.06 logMAR Standard Deviation 0.081
Visual Performance (logMAR) Intermediate (64cm)	-0.01 logMAR Standard Deviation 0.096	0.00 logMAR Standard Deviation 0.090
Visual Performance (logMAR) Near (40cm)	0.10 logMAR Standard Deviation 0.094	0.09 logMAR Standard Deviation 0.089

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.

Subjective 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. The average CLUE vision score for each lens type was reported.

Outcome measures

Outcome measures
Measure	Senofilcon A C3 n=64 Participants Subjects that wore the Test lens in either of the three study periods.	Delefilcon A n=64 Participants Subjects that wore the Control lens in either of the three study periods.
CLUE Vision	55.34 units on a scale Standard Deviation 20.468	55.50 units on a scale Standard Deviation 20.422

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: 1-800-843-2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60