Trial Outcomes & Findings for Evaluation of Visual Acuity With a Reusable Toric Multifocal Contact Lens (NCT NCT05000164)

Last Updated: 2023-01-23

Results Overview

Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling 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

Target enrollment

75 participants

Primary outcome timeframe

4-Week Follow-up

Results posted on

2023-01-23

Participant Flow

A total of 75 subjects were enrolled into this study. Of those enrolled, 72 were dispensed a study lens, while 3 subjects failed to meet all eligibility criteria. Of those dispensed, 62 subjects completed, and 10 subjects discontinued from the study.

Participant milestones

Participant milestones
Measure	Samfilcon A Subjects that were dispensed the study lens.
Overall Study STARTED	72
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Samfilcon A Subjects that were dispensed the study lens.
Overall Study Adverse Event	1
Overall Study Unsatisfactory Visual Response due to Test Article	1
Overall Study Lens Discomfort	3
Overall Study Withdrew Consent during Study	2
Overall Study Subject Withdrawn by PI	2
Overall Study Other Fractured Test Article	1

Baseline Characteristics

Evaluation of Visual Acuity With a Reusable Toric Multifocal Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Samfilcon A n=72 Participants Subjects that were dispensed the study lens.
Age, Continuous	53.4 Years STANDARD_DEVIATION 8.04 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	10 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized White	58 Participants n=5 Participants
Region of Enrollment United States	72 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4-Week Follow-up

Population: All completed subjects.

Outcome measures

Outcome measures
Measure	Samfilcon A n=62 Participants All subjects dispensed the study lens.
Binocular High Luminance High Contrast logMAR Visual Acuity Distance (4m)	-0.13 LogMAR Standard Deviation 0.097
Binocular High Luminance High Contrast logMAR Visual Acuity Near (40cm)	0.09 LogMAR Standard Deviation 0.139
Binocular High Luminance High Contrast logMAR Visual Acuity Intermediate (64cm)	-0.02 LogMAR Standard Deviation 0.115

Adverse Events

Samfilcon 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

Ross Franklin, BAppSc-Optom

Johnson & Johnson Vision Care (JJVC)

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