UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021976
Receipt number R000025333
Scientific Title Clinical evaluation of DAILIES TOTAL 1 performance in a Japanese population.
Date of disclosure of the study information 2016/04/20
Last modified on 2018/10/30 16:14:56

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Basic information

Public title

Clinical evaluation of DAILIES TOTAL 1 performance in a Japanese population.

Acronym

Clinical evaluation of DAILIES TOTAL 1 performance in a Japanese population.

Scientific Title

Clinical evaluation of DAILIES TOTAL 1 performance in a Japanese population.

Scientific Title:Acronym

Clinical evaluation of DAILIES TOTAL 1 performance in a Japanese population.

Region

Japan


Condition

Condition

Habitual current daily disposable soft contact lenses wearers with symptoms of contact lens discomfort.

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this clinical study is to demonstrate non-inferiority of DAILIES TOTAL1 to 1-DAY ACUVUE TruEye for Investigator-rated successful lens centration in Japanese population.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Investigator-rated successful lens centration of Optimal after 7 to 13 days of wearing.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

DAILIES TOTAL 1, then 1-DAY ACUVUE TruEye

Interventions/Control_2

1-DAY ACUVUE TruEye, then DAILIES TOTAL 1

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Must sign an informed consent form;
Habitual current disposable contact lenses wearer.
Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire.
Lenses within power range specified in the protocol.
Vision correctable to 0.8 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit 1.
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.
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria

Currently wearing DAILIES TOTAL 1 or 1-DAY ACUVUE TruEye 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.
Other protocol-specified exclusion criteria may apply.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Motozumi Itoi

Organization

Dogenzaka Itoi Eye Clinic

Division name

Dogenzaka Itoi Eye Clinic

Zip code


Address

1-10-19 Dogenzaka Shibuya-ku, Tokyo

TEL

03-5784-4616

Email

itoi@eyeacademy.net


Public contact

Name of contact person

1st name
Middle name
Last name Mitsugu Watanabe

Organization

Alcon Japan Ltd.

Division name

Phase IV, Clinical & Regulatory Affairs Division Medical Affairs

Zip code


Address

1-23-1 Toranomon, Minato-ku, Tokyo

TEL

03-6899-5054

Homepage URL


Email

mitsugu.watanabe@alcon.com


Sponsor or person

Institute

Alcon Japan Ltd.

Institute

Department

Personal name



Funding Source

Organization

Alcon Japan Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 20 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2016 Year 02 Month 19 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 25 Day

Last follow-up date

2016 Year 09 Month 14 Day

Date of closure to data entry

2016 Year 09 Month 23 Day

Date trial data considered complete

2016 Year 10 Month 04 Day

Date analysis concluded

2016 Year 10 Month 13 Day


Other

Other related information



Management information

Registered date

2016 Year 04 Month 19 Day

Last modified on

2018 Year 10 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025333


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name