UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008873
Receipt number R000010385
Scientific Title The open label parallel intergroup trial about the influence on the tear fluid osmotic pressure by an instillation therapy to dry eye patients
Date of disclosure of the study information 2012/09/18
Last modified on 2023/09/16 11:03:55

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Basic information

Public title

The open label parallel intergroup trial about the influence on the tear fluid osmotic pressure by an instillation therapy to dry eye patients

Acronym

Influence of the tear fluid osmotic pressure on dry eye's eye drops

Scientific Title

The open label parallel intergroup trial about the influence on the tear fluid osmotic pressure by an instillation therapy to dry eye patients

Scientific Title:Acronym

Influence of the tear fluid osmotic pressure on dry eye's eye drops

Region

Japan


Condition

Condition

dry eye

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Influence on tear fluid osmotic pressure and inflammatory cytokine by the eye drop to dry eye patients

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

tear fluid osmotic pressure inflammatory cytokine

Key secondary outcomes

fluorescein corneal staining score
lissamine corneal staining score
breaking up time


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

sodium hyaluronate eye drop

Interventions/Control_2

Rebamipide eye drop

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

A patient aged 20 and over (sex unquestioned)
The patient diagnosed as the example of dry eye decision, or the example of doubt based on dry eye diagnostic criteria (2006)
Hospitalization or visitors; unquestioned
The patient by whom consent is got in written form

Key exclusion criteria

The patient who has merged anterior ocular segment diseases except for dry eye
The patient who is using the patient and the steroid, anti-inflammatory agent, and immunosuppressant
The patient by whom change of eye drops (prescription medicine, OTC medicine) is expected from an inspection till the end of trial drug
The patient for contact lens wearing
The patient who has the eye operation history within 12 months
The patient who enforced insertion of a punctal plug, or a surgical punctal closing way within one month
The patient to whom the examination responsibility doctor or the examination assignment doctor judged the participation in this research to be unsuitable

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Takahashi

Organization

Nippon Medical School

Division name

Ophthalmology

Zip code


Address

1-1-5 Sendagi,Bunkyo-ku,Tokyo

TEL

03-3822-2131

Email

tutomu@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomonaga Takase

Organization

Nippon Medical School

Division name

IRB

Zip code


Address

1-1-5 Sendagi,Bunkyo-ku,Tokyo

TEL

03-3822-2131

Homepage URL


Email

clinicaltrial@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School Ophthalmology

Institute

Department

Personal name



Funding Source

Organization

MHLW

Organization

Division

Category of Funding Organization

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



Other administrative information

Date of disclosure of the study information

2012 Year 09 Month 18 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

Terminated

Date of protocol fixation

2012 Year 08 Month 14 Day

Date of IRB

2012 Year 08 Month 14 Day

Anticipated trial start date

2012 Year 09 Month 18 Day

Last follow-up date

2020 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

2012 Year 09 Month 07 Day

Last modified on

2023 Year 09 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010385


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name