UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042269
Receipt number R000048255
Scientific Title Study title Clinical evaluation of two types of daily disposable silicone hydrogel contact lenses in habitual CL wearers.
Date of disclosure of the study information 2020/10/28
Last modified on 2020/10/28 15:11:51

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Basic information

Public title

Clinical evaluation of two types of daily disposable silicone hydrogel contact lenses in habitual CL wearers.

Acronym

Clinical evaluation of silicone hydrogel contact lenses.

Scientific Title

Study title Clinical evaluation of two types of daily disposable silicone hydrogel contact lenses in habitual CL wearers.

Scientific Title:Acronym

Clinical evaluation of silicone hydrogel contact lenses.

Region

Japan


Condition

Condition

myopia

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Objects To investigate the subjective comfort and lens fit characteristics of Precision 1 compared to 1-Day Acuvue TruEye in a Japanese CL habitual wearers.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1)Corrected visual acuity
2)Lens centration/ fit
3)BUT
4)Subjective questionnaires (comfort, vision, handling, dry eye symptoms)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved 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

Wearing contact lenses

Interventions/Control_2

Switching between two types of contact lenses

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

13 years-old <=

Age-upper limit

40 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Aged 13 to 40 years old must sign the informed consent.
2.Habitual soft/ silicone hydrogel contact lenses wearers.
3.Requiring lenses within the power range of both study contact lenses to be fitted (-0.50D to -6.00D).
4.Vision correctable 0.8 (20/25) or better in each eye at distance with pre-study contact lenses at Baseline.
5.Have subjective symptoms of contact lens discomfort as defined by the Symptomatology eligibility questionnaires.

Key exclusion criteria

1.Current wearing DT1 or 1-Day Acuvue TruEye sphere lenses.
2.Subjects with systemic disease.
3.History of eye surgery/ trauma, use of systemic or local antibiotics or corticosteroids, use of immunomodulatory, pregnancy or breastfeeding within 6 months of the enrollment visit
4.Monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
5.Participation in any clinical trial within 30 days of the enrollment visit.
6.Patient who in judged ineligible as patients in this clinical study by the investigator.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Tatsuya
Middle name
Last name Mimura

Organization

Teikyo University

Division name

School of Medicine, Department of Ophthalmology

Zip code

173-8605

Address

2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan

TEL

03-3964-1211

Email

mimurat@med.teikyo-u.ac.jp


Public contact

Name of contact person

1st name Tatsuya
Middle name
Last name Mimura

Organization

Teikyo University

Division name

School of Medicine, Department of Ophthalmology

Zip code

173-8605

Address

2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan

TEL

03-3964-1211

Homepage URL


Email

mimurat@med.teikyo-u.ac.jp


Sponsor or person

Institute

Teikyo University

Institute

Department

Personal name



Funding Source

Organization

Teikyo University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Nerima West Eye Clinic

Name of secondary funder(s)

Alcon Japan Ltd


IRB Contact (For public release)

Organization

Teikyo University

Address

2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan

Tel

03-3964-1211

Email

mimurat@med.teikyo-u.ac.jp


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

2020 Year 10 Month 28 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

Enrolling by invitation

Date of protocol fixation

2020 Year 10 Month 26 Day

Date of IRB

2020 Year 10 Month 13 Day

Anticipated trial start date

2020 Year 11 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 10 Month 28 Day

Last modified on

2020 Year 10 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048255


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name