UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023722
Receipt number R000027326
Scientific Title Correlation between the change of the ocular surface and the corneal sensory nerve disorder in patients receiving glaucoma therapy drugs.
Date of disclosure of the study information 2016/09/01
Last modified on 2016/11/17 15:41:17

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Basic information

Public title

Correlation between the change of the
ocular surface and the corneal
sensory nerve disorder in patients
receiving glaucoma therapy drugs.

Acronym

Corneal sensory neuropathy in
patients receiving glaucoma therapy
drugs.

Scientific Title

Correlation between the change of the
ocular surface and the corneal
sensory nerve disorder in patients
receiving glaucoma therapy drugs.

Scientific Title:Acronym

Corneal sensory neuropathy in
patients receiving glaucoma therapy
drugs.

Region

Japan


Condition

Condition

glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to
observe correlation between the
change of the ocular surface and the
corneal sensory nerve disorder in
patients receiving glaucoma therapy
drugs.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

To evaluate differences in long nerve fiber density (LNFD) of
corneal parameters between
glaucoma patients and controls
using in vivo confocal microscopy.
Glaucoma patients are sub-grouped according to the period of usage of eye drops.

Key secondary outcomes

corneal sensitivity, epithelial staining, tear volume, etc.


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)Primary open angle glaucoma or ocular hypertension.
2)Patients have been treated with prostaglandine analogs monotherapy.

Key exclusion criteria

1) Any active ocular disease.
2) Subjects unable to tolerate HRTII-RCM.
3) Previous ocular surgery orlaser treatment
4)Patients whom doctor judged to be ineligible for this study.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Shiraishi

Organization

Ehime University

Division name

Ophthalmology

Zip code


Address

Shizukawa, Toon, Ehime, Japan

TEL

089-960-5361

Email

shiraia@m.ehime-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Xiaodong Zheng

Organization

Ehime University

Division name

Ophthalmology

Zip code


Address

Shizukawa, Toon, Ehime, Japan

TEL

089-960-5361

Homepage URL


Email

zheng.xiaodong401@gmail.com


Sponsor or person

Institute

Department of Ophthalmology, Ehime
University

Institute

Department

Personal name



Funding Source

Organization

Senju 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


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

愛媛大学医学部附属病院(愛媛県)、南松山病院(愛媛県)


Other administrative information

Date of disclosure of the study information

2016 Year 09 Month 01 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

Date of protocol fixation

2016 Year 05 Month 10 Day

Date of IRB


Anticipated trial start date

2016 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

Observed research.
This study is evaluated changes of
corneal parameters using confocal
microscopy and ocular surface in
treated glaucoma patients.


Management information

Registered date

2016 Year 08 Month 23 Day

Last modified on

2016 Year 11 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027326


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name