Trial Outcomes & Findings for Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology to Evaluate Overall Visual Acuity. (NCT NCT05361304)

Results Overview

Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance low contrast (HLLC), and low luminance high contrast (LLHC) at distance (4 meters) using an ETDRS (Early Treatment Diabetic Retinopathy Study) 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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

123 participants

Primary outcome timeframe

2-Week Follow-up

Results posted on

2023-07-13

Participant Flow

A total of 123 subjects were enrolled in this study. Of those enrolled, all 123 subjects were dispensed at least one study lens. Of those dispensed, 118 subjects completed the study while 5 subjects were discontinued.

Participant milestones

Participant milestones
Measure	Senofilcon A Contact Lenses Made With the Current Manufacturing Technology Subjects that wore the Senofilcon A contact lenses made with the current manufacturing technology lens during the study.	Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology Subjects that wore the Senofilcon A contact lenses made with a novel manufacturing technology lens during the study.
Overall Study STARTED	62	61
Overall Study COMPLETED	59	59
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Senofilcon A Contact Lenses Made With the Current Manufacturing Technology Subjects that wore the Senofilcon A contact lenses made with the current manufacturing technology lens during the study.	Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology Subjects that wore the Senofilcon A contact lenses made with a novel manufacturing technology lens during the study.
Overall Study Senofilcon A contact lenses made with a novel manufacturing technology Article Not Available.	1	0
Overall Study COVID-19 Related	1	2
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology to Evaluate Overall Visual Acuity.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Senofilcon A Contact Lenses Made With the Current Manufacturing Technology n=62 Participants Subjects that wore the Senofilcon A contact lenses made with the current manufacturing technology lens during the study.	Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology n=61 Participants Subjects that wore the Senofilcon A contact lenses made with a novel manufacturing technology lens during the study.	Total n=123 Participants Total of all reporting groups
Age, Continuous	30.1 Years STANDARD_DEVIATION 5 • n=5 Participants	30.7 Years STANDARD_DEVIATION 5.85 • n=7 Participants	30.4 Years STANDARD_DEVIATION 5.42 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	42 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized White	52 Participants n=5 Participants	52 Participants n=7 Participants	104 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States · participants	62 Participants n=5 Participants	61 Participants n=7 Participants	123 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2-Week Follow-up

Population: All subjects who successfully completed all study visits without a major protocol deviation at 2-Week Follow-up evaluation.

Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance low contrast (HLLC), and low luminance high contrast (LLHC) at distance (4 meters) using an ETDRS (Early Treatment Diabetic Retinopathy Study) 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	Senofilcon A Contact Lenses Made With the Current Manufacturing Technology n=118 eyes Subjects that wore the Senofilcon A contact lenses made with the current manufacturing technology lens during the study.	Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology n=118 eyes Subjects that wore the Senofilcon A contact lenses made with a novel manufacturing technology lens during the study.
Monocular logMAR Visual Acuity High Luminance Low Contrast	0.051 logMAR Standard Deviation 0.1082	0.032 logMAR Standard Deviation 0.0947
Monocular logMAR Visual Acuity Low Luminance High Contrast	0.044 logMAR Standard Deviation 0.1042	0.036 logMAR Standard Deviation 0.0830

PRIMARY outcome

Timeframe: 2-Week Follow-up

Population: All subjects who successfully completed all study visits without a major protocol deviation at 2-Week Follow-up evaluation.

Average daily wear time was assessed by calculating the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day.

Outcome measures

Outcome measures
Measure	Senofilcon A Contact Lenses Made With the Current Manufacturing Technology n=59 Participants Subjects that wore the Senofilcon A contact lenses made with the current manufacturing technology lens during the study.	Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology n=59 Participants Subjects that wore the Senofilcon A contact lenses made with a novel manufacturing technology lens during the study.
Average Daily Wearing Time	14.2 hours Standard Deviation 2.12	14.5 hours Standard Deviation 1.97

SECONDARY outcome

Timeframe: 2-Week Follow-up

Population: All subjects who successfully completed all study visits without a major protocol deviation at 2-Week Follow-up evaluation.

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 comfort score for each lens type was reported.

Outcome measures

Outcome measures
Measure	Senofilcon A Contact Lenses Made With the Current Manufacturing Technology n=59 Participants Subjects that wore the Senofilcon A contact lenses made with the current manufacturing technology lens during the study.	Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology n=59 Participants Subjects that wore the Senofilcon A contact lenses made with a novel manufacturing technology lens during the study.
CLUE Comfort Score	71.53 Units on a scale Standard Deviation 28.439	76.06 Units on a scale Standard Deviation 21.838

SECONDARY outcome

Timeframe: 2-Week Follow-up

Population: All subjects who successfully completed all study visits without a major protocol deviation at 2-Week Follow-up evaluation.

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 Contact Lenses Made With the Current Manufacturing Technology n=59 Participants Subjects that wore the Senofilcon A contact lenses made with the current manufacturing technology lens during the study.	Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology n=59 Participants Subjects that wore the Senofilcon A contact lenses made with a novel manufacturing technology lens during the study.
CLUE Vision Score	73.28 Units on a scale Standard Deviation 24.077	74.26 Units on a scale Standard Deviation 20.615

Adverse Events

Senofilcon A Contact Lenses Made With the Current Manufacturing Technology

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology

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

John R. Buch, OD, MS, FAAO

Johnson & Johnson Vision Care, Inc. (JJVC)

Phone: 800-843-2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60