UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041987
Receipt number R000047922
Scientific Title Investigation of the factors determining contact lens discomfort
Date of disclosure of the study information 2020/11/01
Last modified on 2021/03/06 17:38:25

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Basic information

Public title

Investigation of the factors determining contact lens discomfort

Acronym

Investigation of the factors determining contact lens discomfort

Scientific Title

Investigation of the factors determining contact lens discomfort

Scientific Title:Acronym

Investigation of the factors determining contact lens discomfort

Region

Japan


Condition

Condition

Contact lens discomfort

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation of the factors determining contact lens discomfort

Basic objectives2

Others

Basic objectives -Others

Investigation of the relationship between the degree of contact lens discomfort and tear-film related parameters

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Contact lens discomfort associated symptoms (J-CLDEQ-8 & visual analog scale)

Key secondary outcomes

Before wearing and at the point of 15 min after wearing soft contact lens
1: The radius of tear meniscus
2: The pattern of tear film breakup
3: Non-invasive breakup time of tear film
4: The index which assess the expansion of tear film breakup
5: Distortion value of Mayer's rings of corneal topography


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

Soft contact lens user with contact lens discomfort

Key exclusion criteria

1: The patients with ocular surface inflammatory disease, blepharitis (including meibomitis), and meibomian gland dysfunction
2: The patient who experienced ocular surgery (including eyelid surgery) within 3 months prior to the day of entry
3: Patients who are judged by an investigator to be inappropriate for this study for any other reason

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Norihiko
Middle name
Last name Yokoi

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Ophthalmology

Zip code

6020841

Address

465 Kajii-cho Hirokoji-agaru Kawaramachi-dori Kamigyo-ku, Kyoto, Japan

TEL

075-251-5578

Email

nyokoi@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Norihiko
Middle name
Last name Yokoi

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Ophthalmology

Zip code

6020841

Address

465 Kajii-cho Hirokoji-agaru Kawaramachi-dori Kamigyo-ku, Kyoto, Japan

TEL

075-251-5578

Homepage URL


Email

nyokoi@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Alcon Japan Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


IRB Contact (For public release)

Organization

Kyoto Prefectural University of Medicine, Clinical Research Review Board

Address

465 Kajii-cho Hirokoji-agaru Kawaramachi-dori Kamigyo-ku, Kyoto, Japan

Tel

075-251-5111

Email

kpu@esct.bvits.com


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

京都府立医科大学(Kyoto Prefectural University of Medicine)


Other administrative information

Date of disclosure of the study information

2020 Year 11 Month 01 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

Open public recruiting

Date of protocol fixation

2020 Year 10 Month 02 Day

Date of IRB

2020 Year 12 Month 22 Day

Anticipated trial start date

2021 Year 03 Month 05 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2020 Year 10 Month 02 Day

Last modified on

2021 Year 03 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047922


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name