NCT02710292

Brief Summary

The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE) for Investigator-rated successful lens centration in Japanese population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

April 25, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 3, 2017

Completed
Last Updated

July 2, 2018

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

March 11, 2016

Results QC Date

May 8, 2017

Last Update Submit

May 31, 2018

Conditions

Refractive Error

Outcome Measures

Primary Outcomes (1)

  • Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear

    Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.

    Day 10, each product

Study Arms (2)

DT1, then TE

OTHER

Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.

Device: Delefilcon A contact lensesDevice: Narafilcon A contact lenses

TE, then DT1

OTHER

Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.

Device: Delefilcon A contact lensesDevice: Narafilcon A contact lenses

Interventions

Delefilcon A contact lensesDEVICE
Also known as: DAILIES TOTAL 1®, DT1
DT1, then TETE, then DT1
Narafilcon A contact lensesDEVICE
Also known as: 1-DAY ACUVUE® TruEye®
DT1, then TETE, then DT1

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must sign an informed consent form;
  • Habitual current daily disposable soft contact lenses wearer;
  • Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
  • Lenses within the power range specified in the protocol;
  • Vision correctable to 20/25 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit1;
  • Acceptable lens fit with both study contact lenses;
  • Willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits;

You may not qualify if:

  • Currently wearing DT1 or TE sphere lenses;
  • Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
  • Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator;
  • Eye injury or surgery within 12 weeks immediately prior to enrollment;
  • History of herpetic keratitis, ocular surgery or irregular cornea;
  • Prior refractive surgery;
  • Monocular (only 1 eye with functional vision) or fit with only 1 lens;
  • Participation in any clinical trial within 30 days of the enrollment visit;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Japan, Ltd. for Trial Locations

Tokyo, 107-0052, Japan

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Clinical Manager
Organization
Alcon Japan Ltd.
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Clinical Manager, Clinical Development

    Alcon Japan, Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2016

First Posted

March 16, 2016

Study Start

April 25, 2016

Primary Completion

September 14, 2016

Study Completion

September 14, 2016

Last Updated

July 2, 2018

Results First Posted

October 3, 2017

Record last verified: 2017-05

Locations

JP(1)