Trial Outcomes & Findings for Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Manufacturing Technology (NCT NCT03962790)

Results Overview

Overall comfort score 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 (standard deviation \[SD\] 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

95 participants

Primary outcome timeframe

1-Week Follow-up

Results posted on

2020-08-12

Participant Flow

A total of 95 participants were enrolled in this study however one participant was never randomized due to screen failure therefore, 94 participants were randomized to receive study drug.

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	48	46
Period 1 COMPLETED	45	44
Period 1 NOT COMPLETED	3	2
Period 2 STARTED	45	44
Period 2 COMPLETED	45	44
Period 2 NOT COMPLETED	0	0

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 Adverse Event	0	1
Period 1 Failed to meet all eligibility criteria	1	1
Period 1 No Longer Meets Eligibility Criteria	1	0
Period 1 Withdrawal by Subject	1	0

Baseline Characteristics

Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Manufacturing Technology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Set n=94 Participants All subjects dispensed a study lens.
Age, Continuous	31.7 Years STANDARD_DEVIATION 9.29 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	78 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-Week Follow-up

Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.

Overall comfort score 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 (standard deviation \[SD\] 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.

Outcome measures

Outcome measures
Measure	Etafilcon A Test for Novel n=89 Participants Subjects who wore the Test lens made with a novel manufacturing technology in either the first or second period of the study.	Etafilcon A Control for Current n=89 Participants Subjects that wore the Control lens made with the current manufacturing technology in either the first or second period of the study.
Overall Comfort Score	56.52 Units on a scale Standard Deviation 20.631	55.72 Units on a scale Standard Deviation 22.567

PRIMARY outcome

Timeframe: 1-Week Follow-up

Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.

Overall quality of 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. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.

Outcome measures

Outcome measures
Measure	Etafilcon A Test for Novel n=89 Participants Subjects who wore the Test lens made with a novel manufacturing technology in either the first or second period of the study.	Etafilcon A Control for Current n=89 Participants Subjects that wore the Control lens made with the current manufacturing technology in either the first or second period of the study.
Overall Vision Score	61.65 Units on a scale Standard Deviation 19.161	62.47 Units on a scale Standard Deviation 20.670

SECONDARY outcome

Timeframe: 1-Week follow-up

Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.

Visual acuity measured via Early Treatment Diabetic Retinopathy Study (ETDRS) charts (logMAR) can take on any possible value. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance is reported for each lens type on high contrast dim light and low contrast bright light.

Outcome measures

Outcome measures
Measure	Etafilcon A Test for Novel n=178 Eyes Subjects who wore the Test lens made with a novel manufacturing technology in either the first or second period of the study.	Etafilcon A Control for Current n=178 Eyes Subjects that wore the Control lens made with the current manufacturing technology in either the first or second period of the study.
LogMAR Visual Performance Scale High Contrast Dim	-0.018 logMAR units Standard Deviation 0.1276	-0.017 logMAR units Standard Deviation 0.1173
LogMAR Visual Performance Scale Low Contrast Bright	0.022 logMAR units Standard Deviation 0.0915	0.024 logMAR units Standard Deviation 0.0924

SECONDARY outcome

Timeframe: 1-Week follow-up

Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.

Average daily wear time was calculated as the number of hours between participants reported time of insertion and time of removal of the study lenses, on an average day, at 1-Week follow-up evaluation.

Outcome measures

Outcome measures
Measure	Etafilcon A Test for Novel n=89 Participants Subjects who wore the Test lens made with a novel manufacturing technology in either the first or second period of the study.	Etafilcon A Control for Current n=89 Participants Subjects that wore the Control lens made with the current manufacturing technology in either the first or second period of the study.
Average Daily Wear Time	14.22 Hours Standard Deviation 1.937	14.16 Hours Standard Deviation 1.866

Adverse Events

Etafilcon A Test for Novel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Etafilcon A Control for Current

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

Brian Pall, Director Clinical Science, Vision Care

Johnson & Johnson Vision Care

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