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NCT03341923

Clinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population

Completed NA Results posted Last updated 16 April 2019
What this trial tests

NA trial testing Delefilcon A multifocal contact lenses in Refractive Error in 151 participants. Completed in 5 June 2018.

Timeline
20 December 2017
Primary endpoint
5 June 2018
5 June 2018

Quick facts

Lead sponsorAlcon Research
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposetreatment
Enrollment151
Start date20 December 2017
Primary completion5 June 2018
Estimated completion5 June 2018
Sites4 locations across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Alcon Research — full company profile →

Who can join

40 and older, any sex, with Refractive Error or Presbyopia. 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.

Percentage of Subjects With Investigator-graded Lens Centration of "Optimal" Primary · Day 14, each product

Lens centration was assessed by slit-lamp microscopy and graded on a 5-point scale, where 0=Optimal/Centered and 4=Severe decentration (with corneal exposure). One target eye was randomly selected for analysis.

GroupValue95% CI
DT1MF97.0
AMMF91.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline through study completion, an average of 28 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

DT1MF Ocular
Serious: 0/266 (0%)
Deaths: 0/266
DT1MF Systemic
Serious: 0/133 (0%)
Deaths: 0/133
AMMF Ocular
Serious: 0/268 (0%)
Deaths: 0/268
AMMF Systemic
Serious: 0/134 (0%)
Deaths: 0/134
Other adverse events (4 terms — click to expand)

ReactionSystemDT1MF OcularDT1MF SystemicAMMF OcularAMMF Systemic
Visual impairmentEye disorders
AsthenopiaEye disorders
Dry eyeEye disorders
Ocular discomfortEye disorders

Data from ClinicalTrials.gov NCT03341923 adverse events section.

Sponsor's own description

The purpose of this clinical study is to evaluate DAILIES TOTAL1® Multifocal (DT1MF) contact lenses compared to 1-DAY ACUVUE® Moist® Multifocal (AMMF) contact lenses for investigator-graded lens centration in a Japanese population.

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

Verify or expand the search:

Other trials of Delefilcon A multifocal contact lenses

Trials testing the same drug.

Other recruiting trials for Refractive Error

Currently open trials in the same condition.

Other Alcon Research trials

Trials by the same sponsor.

Verify against primary sources

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/NCT03341923.

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