UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006395
Receipt number R000007588
Scientific Title The effect of diquafosol sodium ophthalmic solutions on the microbial flora of ocular surface
Date of disclosure of the study information 2011/11/15
Last modified on 2011/09/22 18:43:09

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Basic information

Public title

The effect of diquafosol sodium ophthalmic solutions on the microbial flora of ocular surface

Acronym

The effect of eye drop on microbial flora

Scientific Title

The effect of diquafosol sodium ophthalmic solutions on the microbial flora of ocular surface

Scientific Title:Acronym

The effect of eye drop on microbial flora

Region

Japan


Condition

Condition

dry eye and prosthesis

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of diquafosol sodium ophthalmic solutions on the microbial flora of patients with dry eye or prosthesis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

change of microbial flora
quantity of viable bacteria
analysis using 16 S rDNA clone library

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


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

ophthalmic solution

Interventions/Control_2

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

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

dry eye, dry eye suspected, and patients with prosthesis

Key exclusion criteria

The patients who do not consent with this study.
Infectious disease
The patients who are anxious about this study.
The patients who has an allergy for diquafosol sodium ophthalmic solutions.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Eguchi

Organization

Tokushima University Hospital

Division name

Ophthalmologhy

Zip code


Address

3-18-15, Kuramotocho,Tokushima-shi

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Tokushima University Hospital

Division name

Ophthalmology

Zip code


Address


TEL

088-633-7163

Homepage URL


Email



Sponsor or person

Institute

Tokushima University Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Ophthalmology, Tokushima University Hospital

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

2011 Year 11 Month 15 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

Preinitiation

Date of protocol fixation

2011 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 11 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 09 Month 22 Day

Last modified on

2011 Year 09 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007588


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name