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NCT03341923 Clinical Trial

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

Presbyopia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03341923
Other study ID # CLJ369-P001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 20, 2017
Est. completion date June 5, 2018

Study information
Verified date March 2019
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 151
Est. completion date June 5, 2018
Est. primary completion date June 5, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Delefilcon A multifocal contact lenses
Silicone hydrogel multifocal contact lenses for daily disposable wear
• Etafilcon A multifocal contact lenses
Hydrogel multifocal contact lenses for daily disposable wear

Locations
Country Name City State
Japan Alcon Investigative Site Koto-Ku Tokyo
Japan Alcon Investigative Site Nakano-ku Tokyo
Japan Alcon Investigative Site Shinagawa-Ku Tokyo
Japan Alcon Investigative Site Taito Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Day 14, each product
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