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

ID: NCT03341923
Status: Recruiting
Phase: N/A
Start Date: December 20, 2017
First Submitted: November 09, 2017
Last Updated: February 22, 2018
Results: N/A
Organization: Alcon Research
Sponsors & Collaborators: Alcon Research
Location: Japan
Conditions: Refractive Error, Presbyopia
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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.
Condition or disease Intervention/treatment Phase

Presbyopia

Refractive Error

Device: Delefilcon A multifocal contact lenses
Other Names
DAILIES TOTAL 1® Multifocal
Device: Etafilcon A multifocal contact lenses
Other Names
1-DAY ACUVUE® Moist® Multifocal
N/A

Tracking Information

First Submitted DateNovember 09, 2017
Last Update Posted DateFebruary 22, 2018
Actual Start DateDecember 20, 2017
Anticipated Completion DateJune 01, 2018
Actual Primary Completion DateJune 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Investigator-graded lens centration of "Optimal" [Time Frame: Day 14, each product]

    Lens centration will be assessed by slit-lamp microscopy and graded on a 5-point scale, where 0=Optimal/Centered and 4=Severe decentration (with corneal exposure)

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleClinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population
Official TitleClinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population
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.

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
134
Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Single
Primary Purpose
Treatment
Conditions
Presbyopia
Refractive Error
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Device: Delefilcon A multifocal contact lenses

Silicone hydrogel multifocal contact lenses for daily disposable wear

Other Names
DAILIES TOTAL 1® Multifocal
Device: Etafilcon A multifocal contact lenses

Silicone hydrogel multifocal contact lenses for daily disposable wear

Other Names
1-DAY ACUVUE® Moist® Multifocal
Study Groups/Cohorts
DT1MF, then AMMF
Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product will be in both eyes for 14 +/- 3 days.

AMMF, then DT1MF
Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product will be worn in both eyes for 14 +/- 3 days.

Study Arms
Other AMMF, then DT1MF
Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product will be worn in both eyes for 14 +/- 3 days.
Device : Delefilcon A multifocal contact lenses
Silicone hydrogel multifocal contact lenses for daily disposable wear

Other AMMF, then DT1MF
Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product will be worn in both eyes for 14 +/- 3 days.
Device : Etafilcon A multifocal contact lenses
Silicone hydrogel multifocal contact lenses for daily disposable wear

Other DT1MF, then AMMF
Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product will be in both eyes for 14 +/- 3 days.
Device : Delefilcon A multifocal contact lenses
Silicone hydrogel multifocal contact lenses for daily disposable wear

Other DT1MF, then AMMF
Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product will be in both eyes for 14 +/- 3 days.
Device : Etafilcon A multifocal contact lenses
Silicone hydrogel multifocal contact lenses for daily disposable wear

Arm Intervention/Treatment
Other AMMF, then DT1MF
Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product will be worn in both eyes for 14 +/- 3 days.
Device : Delefilcon A multifocal contact lenses
Other AMMF, then DT1MF
Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product will be worn in both eyes for 14 +/- 3 days.
Device : Etafilcon A multifocal contact lenses
Other DT1MF, then AMMF
Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product will be in both eyes for 14 +/- 3 days.
Device : Delefilcon A multifocal contact lenses
Other DT1MF, then AMMF
Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product will be in both eyes for 14 +/- 3 days.
Device : Etafilcon A multifocal contact lenses

Recruitment Information

Recruitment Status:Recruiting
Enrollment134
Completion DateJune 01, 2018
Eligibility Criteria: Inclusion Criteria:
- Sign informed consent.
- Habitually wear multifocal soft/ silicone hydrogel contact lenses
- Require a near spectacle ADD of +0.50D 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.
- Other protocol-defined inclusion criteria may apply

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
- Other protocol-defined exclusion criteria may apply
GenderAll
Age40 Years to N/A
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Listed Location Countries
Japan

Administrative Information

NCT Number:NCT03341923
Other Study ID Numbers
CLJ369-P001
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product 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
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Alcon Research
Collaborators
Not Available
Investigators
Not Available