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

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ClinicalTrials.gov Identifier: NCT03341923
Recruitment Status : Completed
First Posted : November 14, 2017
Results First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Refractive Error Presbyopia Device: Delefilcon A multifocal contact lenses Device: Etafilcon A multifocal contact lenses Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population
Actual Study Start Date : December 20, 2017
Actual Primary Completion Date : June 5, 2018
Actual Study Completion Date : June 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
DT1MF, then AMMF
Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.
Device: Delefilcon A multifocal contact lenses
Silicone hydrogel multifocal contact lenses for daily disposable wear
Other Name: DAILIES TOTAL 1® Multifocal

Device: Etafilcon A multifocal contact lenses
Hydrogel multifocal contact lenses for daily disposable wear
Other Name: 1-DAY ACUVUE® Moist® Multifocal

AMMF, then DT1MF
Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.
Device: Delefilcon A multifocal contact lenses
Silicone hydrogel multifocal contact lenses for daily disposable wear
Other Name: DAILIES TOTAL 1® Multifocal

Device: Etafilcon A multifocal contact lenses
Hydrogel multifocal contact lenses for daily disposable wear
Other Name: 1-DAY ACUVUE® Moist® Multifocal




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341923


Locations
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Japan
Alcon Investigative Site
Koto-Ku, Tokyo, Japan, 136-0071
Alcon Investigative Site
Nakano-ku, Tokyo, Japan, 164-0001
Alcon Investigative Site
Shinagawa-Ku, Tokyo, Japan, 141-0021
Alcon Investigative Site
Taitō, Tokyo, Japan, 110-0005
Sponsors and Collaborators
Alcon Research
  Study Documents (Full-Text)

Documents provided by Alcon Research:
Study Protocol  [PDF] January 22, 2018
Statistical Analysis Plan  [PDF] March 16, 2015


Additional Information:
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03341923     History of Changes
Other Study ID Numbers: CLJ369-P001
First Posted: November 14, 2017    Key Record Dates
Results First Posted: April 16, 2019
Last Update Posted: April 16, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Alcon Research:
contact lenses
lens centration
multifocal
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases