UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029333
Receipt number R000033506
Scientific Title The efficacy of DIQUAS ophthalmic solution 3% for dry eye patients before cataract surgery
Date of disclosure of the study information 2017/10/02
Last modified on 2023/06/28 10:57:46

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Basic information

Public title

The efficacy of DIQUAS ophthalmic solution 3% for dry eye patients before cataract surgery

Acronym

The efficacy of DIQUAS ophthalmic solution 3% for dry eye patients before cataract surgery

Scientific Title

The efficacy of DIQUAS ophthalmic solution 3% for dry eye patients before cataract surgery

Scientific Title:Acronym

The efficacy of DIQUAS ophthalmic solution 3% for dry eye patients before cataract surgery

Region

Japan


Condition

Condition

Dry eye

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the change of dry eye findings and refraction data

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Dry eye examination results, corneal curvature radius, refraction data and adverse event

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Diquafosol Ophthalmic Solution 3%

Interventions/Control_2

Artificial tear Mytear ophthalmic solution

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

50 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

To have a plan to be given a cataract surgery.

Key exclusion criteria

Being on dry eye medication.
Using contact lens.
Having an infection eye disease.
Having a complication of an eye disease which might have an influence on evaluation of this study.
Having a history of an allergic reaction to the ingredients used in this study.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Masayo
Middle name
Last name Hashimoto

Organization

Santen Pharmaceutical Co., Ltd.

Division name

Japan Medical Affairs group, Development Management Department, Japan Business

Zip code

530-8552

Address

4-20, Ofukacho, Kita-ku, Osaka

TEL

06-4802-9337

Email

clinical@santen.co.jp


Public contact

Name of contact person

1st name Yoshiaki
Middle name
Last name Yamada

Organization

Santen Pharmaceutical Co., Ltd.

Division name

Japan Medical Affairs group, Development Management Department, Japan Business

Zip code

530-8552

Address

4-20, Ofukacho, Kita-ku, Osaka

TEL

06-4802-9604

Homepage URL


Email

clinical@santen.co.jp


Sponsor or person

Institute

Santen Pharmaceutical Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Santen Pharmaceutical Co., 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

Review Board of Human Rights and Ethics for Clinical Studies Ethics Review Committee

Address

13-2 Ichibancho, Chiyoda-ku, Tokyo

Tel

03-5213-0028

Email

info@hurecs.org


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

2017 Year 10 Month 02 Day


Related information

URL releasing protocol

None

Publication of results

Published


Result

URL related to results and publications

https://www.mdpi.com/2077-0383/11/3/710/htm

Number of participants that the trial has enrolled

69

Results

Refer to paper

Results date posted

2023 Year 06 Month 28 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2022 Year 01 Month 28 Day

Baseline Characteristics

Refer to paper

Participant flow

Refer to paper
Efficacy evaluation of ophthalmic solutions was not performed due to insufficient number of cases included.

Adverse events

The following adverse events were observed in this study.
Influenza
Heaviness of the right upper eyelid
Corneal edema
Foreign body sensation in the eye
Eye discharge
Increased nasal discharge

Outcome measures

Dry eye examination results, corneal curvature radius, refraction data and adverse event

Plan to share IPD

The data presented in this study are available on request from the corresponding author.

IPD sharing Plan description

The data presented in this study are available on request from the corresponding author.


Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 08 Month 04 Day

Date of IRB

2007 Year 08 Month 25 Day

Anticipated trial start date

2017 Year 10 Month 02 Day

Last follow-up date

2018 Year 08 Month 09 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 09 Month 28 Day

Last modified on

2023 Year 06 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033506


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name