NCT03713281

Evaluation of a Toric Multifocal Contact Lens Manufactured in Etafilcon Material in a Low ADD Hyperopic Population

Completed Results posted Last updated 25 April 2025

What this trial tests

trial testing Toric Multifocal etafilcon A with PVP in Visual Acuity in 30 participants. Completed in 19 February 2019.

Timeline

4 October 2018

Primary endpoint
19 February 2019

19 February 2019

Quick facts

Lead sponsor	Johnson & Johnson Vision Care, Inc.
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	4 October 2018
Primary completion	19 February 2019
Estimated completion	19 February 2019
Sites	1 location across United States

Drugs / interventions tested

• Toric Multifocal etafilcon A with PVP

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.

Distance Visual Acuity (logMAR) Primary · 2-Week Follow-up

High Luminance, high contrast distance (4 meters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows: 0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity.

Group	Value	95% CI
Toric Multifocal Etafilcon A With PVP	-0.13	± 0.095

Near Visual Acuity (logMAR) Primary · 2-Week Follow-up

High Luminance, high contrast near (40 centimeters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows:0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity.

Group	Value	95% CI
Toric Multifocal Etafilcon A With PVP	0.06	± 0.080

Sponsor's own description

The study is a bilateral, single-masked, single-arm, 3-visit dispensing study. There will be one study treatment, with the subject being in the treatment for approximately 12-16 days.

Publications & conference data

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