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OpenTrials
Completed

NCT Number: NCT03341923

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

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.

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Key information

Conditions

Refractive Error Eye Diseases Presbyopia Refractive Errors

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigative Site, Koto-Ku, Tokyo, Japan

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About this study

Subjects will be randomly assigned to one of two sequences of investigational product wear ((DT1MF→AMMF, AMMF→DT1MF). Each product will be worn in both eyes for at least 11 days.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sign informed consent
  • Habitually wear multifocal soft/ silicone hydrogel contact lenses
  • Require a near spectacle ADD of +0.50 diopters (D) to +2.50D (inclusive)
  • Correctable to 20/30 Snellen or 0.2 logarithm minimum angle of resolution (logMAR) or better in each eye at distance
  • Willing to wear contact lenses and attend all study visits

Exclusion criteria

  • Currently wearing DAILIES TOTAL 1® Multifocal or 1-DAY ACUVUE® Moist® Multifocal contact lenses
  • Any eye condition that would make contact lens wear unadvisable
  • Any use of medication that would make contact lens wear unadvisable
  • Prior refractive surgery

Treatment and study plan

Delefilcon A multifocal contact lenses

Device

Silicone hydrogel multifocal contact lenses for daily disposable wear

Other names: DAILIES TOTAL 1® Multifocal

Etafilcon A multifocal contact lenses

Device

Hydrogel multifocal contact lenses for daily disposable wear

Other names: 1-DAY ACUVUE® Moist® Multifocal

Primary outcomes

  1. Percentage of Subjects With Investigator-graded Lens Centration of "Optimal"

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 14, 2017
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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