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NCT03322423

Evaluation of Two Marketed Multifocal Contact Lenses

Completed NA Results posted Last updated 8 January 2019
What this trial tests

NA trial testing Multifocal Contact Lens 1 in Visual Performance in 78 participants. Completed in 4 November 2017.

Timeline
11 September 2017
Primary endpoint
4 November 2017
4 November 2017

Quick facts

Lead sponsorJohnson & Johnson Vision Care, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposetreatment
Enrollment78
Start date11 September 2017
Primary completion4 November 2017
Estimated completion4 November 2017
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

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

Who can join

Adults 40 to 70, any sex, with Visual Performance. 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 Binocular Visual Acuity Primary · 1-Week Follow-up

Distance visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts.

GroupValue95% CI
Delefilcon A-0.056± 0.0842
Nesofilcon A-0.075± 0.0759
Near Binocular Visual Acuity Primary · 1-Week Follow-up

Near visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using reduced Guillon-Poling Charts.

GroupValue95% CI
Delefilcon A0.143± 0.1084
Nesofilcon A0.143± 0.1117
Overall Quality of Vision Secondary · 1-Week Follow-up

Overall quality of 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.

GroupValue95% CI
Delefilcon A47.4± 17.81
Nesofilcon A49.3± 19.43

Sponsor's own description

This is a single-masked, randomized, cross-over, dispensing, 6- visit pilot study. The purpose of this clinical study is to evaluate the performance of two marketed multifocal lenses.

Publications & conference data

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

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Other trials of Multifocal Contact Lens 1

Trials testing the same drug.

Other Johnson & Johnson Vision Care, Inc. trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03322423.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing