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

Primary Purpose

Refractive Error, Presbyopia

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Delefilcon A multifocal contact lenses
Etafilcon A multifocal contact lenses
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Error focused on measuring contact lenses, lens centration, multifocal

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

DT1MF, then AMMF

AMMF, then DT1MF

Arm Description

Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.

Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 9, 2017
Last Updated
March 26, 2019
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT03341923
Brief Title
Clinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population
Official Title
Clinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
June 5, 2018 (Actual)
Study Completion Date
June 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error, Presbyopia
Keywords
contact lenses, lens centration, multifocal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DT1MF, then AMMF
Arm Type
Other
Arm Description
Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.
Arm Title
AMMF, then DT1MF
Arm Type
Other
Arm Description
Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.
Intervention Type
Device
Intervention Name(s)
Delefilcon A multifocal contact lenses
Other Intervention Name(s)
DAILIES TOTAL 1® Multifocal
Intervention Description
Silicone hydrogel multifocal contact lenses for daily disposable wear
Intervention Type
Device
Intervention Name(s)
Etafilcon A multifocal contact lenses
Other Intervention Name(s)
1-DAY ACUVUE® Moist® Multifocal
Intervention Description
Hydrogel multifocal contact lenses for daily disposable wear
Primary Outcome Measure Information:
Title
Percentage of Subjects With Investigator-graded Lens Centration of "Optimal"
Description
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.
Time Frame
Day 14, each product

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Alcon Investigative Site
City
Koto-Ku
State/Province
Tokyo
ZIP/Postal Code
136-0071
Country
Japan
Facility Name
Alcon Investigative Site
City
Nakano-ku
State/Province
Tokyo
ZIP/Postal Code
164-0001
Country
Japan
Facility Name
Alcon Investigative Site
City
Shinagawa-Ku
State/Province
Tokyo
ZIP/Postal Code
141-0021
Country
Japan
Facility Name
Alcon Investigative Site
City
Taitō
State/Province
Tokyo
ZIP/Postal Code
110-0005
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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