NCT05222880

Evaluation of a Daily Disposable Silicone Hydrogel Multifocal Contact Lens in Myopes and Hyperopes

Completed NA Results posted Last updated 13 April 2023

What this trial tests

NA trial testing JJVC Investigational Multifocal Contact Lenses manufactured in senofilcon A C3 in Visual Acuity in 140 participants. Completed in 28 February 2022.

Timeline

6 January 2022

Primary endpoint
28 February 2022

28 February 2022

Quick facts

Lead sponsor	Johnson & Johnson Vision Care, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	140
Start date	6 January 2022
Primary completion	28 February 2022
Estimated completion	28 February 2022
Sites	12 locations across United States

Drugs / interventions tested

• JJVC Investigational Multifocal Contact Lenses manufactured in senofilcon A C3

Conditions studied

• Visual Acuity — all drugs for Visual Acuity →

Sponsor

Johnson & Johnson Vision Care, Inc. — full company profile →

Who can join

Adults 40 to 70, any sex, with Visual Acuity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Binocular logMAR Visual Acuity Primary · 1-Week Follow-up

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

Distance(4m)

Group	Value	95% CI
Test (Senofilcon A C3)	-0.098	± 0.0854

Intermediate (64cm)

Group	Value	95% CI
Test (Senofilcon A C3)	-0.043	± 0.0797

Near (40cm)

Group	Value	95% CI
Test (Senofilcon A C3)	0.0797	± 0.1077

CLUE Vision Score Primary · 1-Week Follow-up

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 sphere stratum (Hype

Hyperopes

Group	Value	95% CI
Test (Senofilcon A C3)	52.30	± 19.121

Myopes

Group	Value	95% CI
Test (Senofilcon A C3)	63.27	± 19.031

Proportion of Eyes With Unacceptable Lens Fitting Primary · Up to 1-Week Follow-up

Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion, the 1-week follow-up and any unscheduled visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported.

Group	Value	95% CI
Test (Senofilcon A C3)	0

Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings Primary · Up to 1-Week Follow-up

Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported

Group	Value	95% CI
Test (Senofilcon A C3)	0

CLUE Vision Score Secondary · 1-Week Follow-up

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 sphere stratum (Hype

Hyperopes

Group	Value	95% CI
Test (Senofilcon A C3)	52.30	± 19.121

Myopes

Group	Value	95% CI
Test (Senofilcon A C3)	63.27	± 19.031

CLUE Comfort Score Secondary · 1-Week Follow-up

Subjective comfort 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 was reported. The pre-speci

Group	Value	95% CI
Test (Senofilcon A C3)	72.60	± 20.696

CLUE Handling Score Secondary · 1-Week Follow-up

Subjective Handling 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 handling score was reported. The pre-spe

Group	Value	95% CI
Test (Senofilcon A C3)	67.56	± 20.619

Proportion of Subject Achieving Optimal Lens Pair in 4 Lenses or Less Secondary · Up to 1-Week Follow-up

The number of lenses to achieve the optimal pair for each subject was calculated as the original pair (2) plus all the required modifications to reach the optimal pair. In this study the minimum number of lenses per subject used was 2 where the maximum possible number of lenses used was 10. The data was dichotomized as Y=1 if the subject was able to achieve optimal lens pair in 4 lenses or lenses or less and 0 otherwise. A lens modification was performed if the subject reports unsatisfactory vision or was unable to obtain 20/30 distance visual acuity in both eyes. If the subject reported satis

Group	Value	95% CI
Test (Senofilcon A C3)	1

Sponsor's own description

This is a single-masked, single-arm, dispensing clinical trial that will evaluate vision, eye health and fit acceptance.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.