UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020023
Receipt number R000017977
Scientific Title Bacteriological investigation of the human conjunctival flora under a long-term treatment with topical ophthalmic solutions
Date of disclosure of the study information 2015/12/10
Last modified on 2017/06/01 14:15:25

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Basic information

Public title

Bacteriological investigation of the human conjunctival flora under a long-term treatment with topical ophthalmic solutions

Acronym

Bacteriological nvestigation of the conjunctival flora under a long-term topical treatment

Scientific Title

Bacteriological investigation of the human conjunctival flora under a long-term treatment with topical ophthalmic solutions

Scientific Title:Acronym

Bacteriological nvestigation of the conjunctival flora under a long-term topical treatment

Region

Japan


Condition

Condition

Patients with glaucoma under topical ophthalmic treatment

Patients with a long-term steroid instillation

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Bacteriological analysis of the human conjunctival flora under a long-term instillation of ophthalmic solutions

Basic objectives2

Others

Basic objectives -Others

Analysis of the influence of ophthalmic topical treatment ofn the conjunctival flora

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Positive isolation rate of bacteria from the conjuncitiva.
Bacterial prevalence in the conjunctiva flora.
Antibiotic susceptibility of isolated bacteria

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

1) Glaucoma patients treated with ophthalmic solutions for reduction of intraocular pressurein more than one year.

2) Patients treated with steroid ophthalmic solutions more than three months.

Key exclusion criteria

1) Patients with a history of antibiotics administration within two weeks prior to the study,
2) Patients suspecting any infectious ocular diseases.
3) Patients whom investigators considered not to be are eligible.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazunori Miyata

Organization

Miyata eye Hospital

Division name

Miyata eye Hospital

Zip code


Address

6-3 Kurahara Miyakonojo Miyazaki 885-0051

TEL

0986-22-1441

Email

miyata@miyata-med.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryohei Nejima

Organization

Miyata eye Hospital

Division name

Miyata eye Hospital

Zip code


Address

6-3 Kurahara Miyakonojo Miyazaki 885-0051

TEL

0986-22-1441

Homepage URL


Email

nejima@miyata-med.ne.jp


Sponsor or person

Institute

Miyata eye Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

2015 Year 12 Month 10 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

2014 Year 07 Month 24 Day

Date of IRB


Anticipated trial start date

2014 Year 09 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

prospective cohort study
patients who comes to Miyata Eye Hospital


Management information

Registered date

2015 Year 12 Month 01 Day

Last modified on

2017 Year 06 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017977


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name