UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042790
Receipt number R000048841
Scientific Title Web questionnaire survey on the use of eye drops for patients with dry eye
Date of disclosure of the study information 2020/12/18
Last modified on 2022/03/03 15:39:46

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Basic information

Public title

Web questionnaire survey on the use of eye drops for patients with dry eye

Acronym

Web questionnaire survey on the use of eye drops for patients with dry eye

Scientific Title

Web questionnaire survey on the use of eye drops for patients with dry eye

Scientific Title:Acronym

Web questionnaire survey on the use of eye drops for patients with dry eye

Region

Japan


Condition

Condition

Dry eye

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We ask a questionnaire for patients with dry eye. We investigate the use of eye drops in treatment for dry eye, and the effects of subjective symptoms, quality of life and patient satisfaction by the use.

Basic objectives2

Others

Basic objectives -Others

Relationship between drug adherence status and background of patients

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The Use of eye drops in treatment for dry eye, and the reason how patients used
The effects of subjective symptoms, quality of life and patient satisfaction by the use

Key secondary outcomes



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

Patients diagnosed dry eye and prescribed an eye drop in the treatment (Diquafosol sodium ophthalmic solution, Sodium hyaluronate ophthalmic solution 0.1%, or Rhebamipide opthhalmic suspension)
Patients used the eye drop for more than 1 month.

Key exclusion criteria

Medical professionals (doctors, pharmacists, nurses, etc.)
Patients engaged in pharmaceuticals and medical devices industry
Patients engaged in pharmaceuticals distributor
Patients engaged in information provision services, research services, and advertising
Patients with diabetes mellitus or ocular infection
Patients used eye drops in the treatment for glaucoma or seasonal allergic conjunctivitis
Patients had a past history of ophthalmic surgery within 1 month
Patients used a punctal plug and performed a punctal closure procedure
Patients visited an eye clinic for the treatment of dry eye more over 3 months
Patients used eye drops in the treatment for dry eye in combination

Target sample size

3000


Research contact person

Name of lead principal investigator

1st name Miki
Middle name
Last name Uchino

Organization

Dry eye society

Division name

Ophthalmology

Zip code

6028566

Address

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto

TEL

03-3473-0400

Email

uchinomiki@keio.jp


Public contact

Name of contact person

1st name Miki
Middle name
Last name Uchino

Organization

Dry eye society

Division name

Ophthalmology

Zip code

6028566

Address

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto

TEL

03-3473-0400

Homepage URL


Email

uchinomiki@keio.jp


Sponsor or person

Institute

Dry eye society

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

Medical Corporation TOUKEIKAI Kitamachi Clinic ERB

Address

1, 3, Kichijoji Kita-cho, Musashino-shi, Tokyo

Tel

070-5011-8550

Email

shingo-namiki@cmicgroup.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



Other administrative information

Date of disclosure of the study information

2020 Year 12 Month 18 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.3390/jcm11020367

Number of participants that the trial has enrolled

2645

Results

The proportion of participants who instilled at the frequency specified in the package insert was 10.2%.
The improvement in subjective symptoms score was significantly greater in the fixed-use group than the non-fixed use group (p = 0.0027).

Results date posted

2022 Year 03 Month 03 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2022 Year 01 Month 12 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 12 Month 08 Day

Date of IRB

2020 Year 12 Month 16 Day

Anticipated trial start date

2020 Year 12 Month 17 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Web questionnaire survey


Management information

Registered date

2020 Year 12 Month 18 Day

Last modified on

2022 Year 03 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048841


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name