NCT04615507

Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population; Part 2

Completed NA Results posted Last updated 1 April 2022

What this trial tests

NA trial testing JJVC Investigational Multifocal Contact Lens in Visual Acuity in 71 participants. Completed in 9 December 2020.

Timeline

9 October 2020

Primary endpoint
9 December 2020

9 December 2020

Quick facts

Lead sponsor	Johnson & Johnson Vision Care, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	71
Start date	9 October 2020
Primary completion	9 December 2020
Estimated completion	9 December 2020
Sites	6 locations across United States

Drugs / interventions tested

• JJVC Investigational Multifocal Contact Lens
• Dailies Total 1® Multifocal Contact Lens

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.

Visual Performance LogMAR Primary · 1-Week Follow-up within each wearing period

Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters), intermediate (64 centimeters) and near (40 centimeters) under high luminance high contrast lighting condition 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 meters), the acceptable range for the chart luminance was 10.5-10.7 EV (181 208 cd/m2). For Intermediate (64cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). L

Distance (4m)

Group	Value	95% CI
Test	-0.12	± 0.108
Control	-0.13	± 0.088

Intermediate (64cm)

Group	Value	95% CI
Test	-0.06	± 0.089
Control	-0.04	± 0.106

Near (40cm)

Group	Value	95% CI
Test	0.08	± 0.140
Control	0.10	± 0.136

Vision Scores Secondary · 1-Week Follow-up within each wearing period

Overall vision scores were 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 leans type was

Group	Value	95% CI
Test	59.72	± 18.310
Control	53.98	± 15.108

Sponsor's own description

This is a 6-visit, subject-masked, multi-site, 2×3 crossover dispensing trial that will last approximately 2 - 4 months.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Silicone hydrogel versus hydrogel soft contact lenses for differences in patient-reported eye comfort and safety.
   Haworth K, Travis D, Leslie L, Fuller D, et al · · 2023 · cited 10× · PMID 37724689 · DOI 10.1002/14651858.cd014791.pub2