UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020408
Receipt number R000023569
Scientific Title The short-term and long-term effect on meibomian gland dysfunction with dry eye by Diquafosol Sodium eye drop
Date of disclosure of the study information 2016/01/01
Last modified on 2018/03/16 09:19:22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The short-term and long-term effect on meibomian gland dysfunction with dry eye by Diquafosol Sodium eye drop

Acronym

The effect on MGD with dry eye by Diquafosol Sodium eye drop

Scientific Title

The short-term and long-term effect on meibomian gland dysfunction with dry eye by Diquafosol Sodium eye drop

Scientific Title:Acronym

The effect on MGD with dry eye by Diquafosol Sodium eye drop

Region

Japan


Condition

Condition

Normal eyes

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Diquafosol, which is commercially available in Japan as a novel dry eye therapy, is a P2Y2 purinergic receptor agonist that activates P2Y2 receptors on the ocular surface, leading to rehydration through activation of the fluid pump of the accessory lacrimal glands on the conjunctival tissue and conjunctival goblet cell secretion of ocular mucins.
P2Y2 receptors exist in the meibomian glands as well. The present study was designed to evaluate the shor-term and long-term effect of diquafosol 3% ophthalmic solution (Diquas, Santen, Osaka, Japan) when applied to normal.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Lipid layer thickness

Key secondary outcomes

Symtoms, tear-film break up time (TBUT), tear meniscus, meibography, Schirmer tess


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Diquafosol eyedrop 6 times a day for 4 weeks

Interventions/Control_2

Artificial tear eyedrop 6 times a day for 4 weeks

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Normal eyes without dry eye symptoms

Key exclusion criteria

Normal subjects with any other ocular disease (except cataract, refractive error) .
The history of contact lens wear. Subjects without written informed consent.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Reiko Arita

Organization

Itoh Clinic

Division name

Department of Ophthalmology

Zip code


Address

626-11 Minami-Nakano, Minuma, Saitama, Saitama 337-0042, Japan

TEL

048-686-5588

Email

arita.reiko@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Arita Reiko

Organization

Itoh Clinic

Division name

Department of Ophthalmology

Zip code


Address

626-11 Minami-Nakano, Minuma, Saitama, Saitama 337-0042, Japan

TEL

048-686-5588

Homepage URL


Email

arita.reiko@gmail.com


Sponsor or person

Institute

Itoh Clinic

Institute

Department

Personal name



Funding Source

Organization

Itoh Clinic

Organization

Division

Category of Funding Organization

Other

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

伊藤医院(埼玉県)


Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2015 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 01 Day

Last follow-up date

2017 Year 12 Month 31 Day

Date of closure to data entry

2018 Year 01 Month 31 Day

Date trial data considered complete

2018 Year 01 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 12 Month 31 Day

Last modified on

2018 Year 03 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023569


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name