UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010912
Receipt number R000012770
Scientific Title The curative effect of Diquafosol Sodium ophthalmic solution 3% to the diabetic who has the amount fall of tear fluid secretion, and an anterior-epithelium-of-cornea obstacle.
Date of disclosure of the study information 2013/06/10
Last modified on 2015/07/17 17:11:33

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Basic information

Public title

The curative effect of Diquafosol Sodium ophthalmic solution 3% to the diabetic who has the amount fall of tear fluid secretion, and an anterior-epithelium-of-cornea obstacle.

Acronym

The curative effect of Diquafosol Sodium ophthalmic solution 3% to the diabetic who has the amount fall of tear fluid secretion, and an anterior-epithelium-of-cornea obstacle.

Scientific Title

The curative effect of Diquafosol Sodium ophthalmic solution 3% to the diabetic who has the amount fall of tear fluid secretion, and an anterior-epithelium-of-cornea obstacle.

Scientific Title:Acronym

The curative effect of Diquafosol Sodium ophthalmic solution 3% to the diabetic who has the amount fall of tear fluid secretion, and an anterior-epithelium-of-cornea obstacle.

Region

Japan


Condition

Condition

diabetes with an anterior-epithelium-of-cornea obstacle

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The clinical efficacy of the eye drop Diquafosol Sodium ophthalmic solution (DIQUAS 3%) to the amount of tear fluid secretion, the tear film before a cornea, and ocular surface in the diabetic accompanied by tear fluid reduction is examined.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Change before and behind the medical treatment of the Schirmer examination I method

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

DIQUAS ophthalmic solution


Interventions/Control_2

Hyalein ophthalmic solution

Interventions/Control_3

Soft Santear

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.The patients aged 20 and over in the time of consent acquisition.
2.The patient who the amount fall of tear fluid secretion was permitted to by the Schirmer examination (5mm or less), and was permitted the anterior-epithelium-of-cornea obstacle by intravital staining (a fluorescein examination or a rose bengal examination).
3.The patients whose the HbA1c values is 6.5% or more (NGSP value) at the time of the start of clinical study or within 1 month of the start.
4.After being given to sufficient explanation in the participation in this research and understanding the main point and the details of this research enough -- a patient -- the patient by whom the document consent by the free intention of the person himself/herself was got.

Key exclusion criteria

1.The user of a contact lens (used within one week or the existing patient who is going to use a contact lens during medical treatment observation)
2.The patient who has the past of cornea refractive surgery.
3.The patient currently diagnosed as meibomian gland dysfunction.
4.The patient suffered from eye infection or a serious allergic conjunctival disease.
5.The patient currently diagnosed as the cicatricial angle conjunctival disease (eye pemphigoid, and Stevens-Johnson syndrome and alkali externally caused injury are included).
6.The patient who has the past of an inner eye operation (laser surgery is included) within three months before an observation start.
7.The patient who was continuing the medical treatment (a punctum plug insertion way, a surgical punctum closing way, etc.) aiming at the blockade of punctum before the observation term start till less than one month.
8.The patient who is performing dry eye auxiliary medical treatment which has on pharmacometrics, such as glasses for dry eye protection.
9.The patient who has eyeblink insufficiency.
10.The patient who has a schedule which adds an applying- ophthalmic solution during exam.
11.The patient with the schedule which uses the medicine (treatment) provided in the regulation about a concomitant drug (treatment) during exam.
12.The patient who had complications of the heart, liver, the kidney, blood dyscrasia, and others, and was judged to be unsuitable on pharmacometrics.
13.The patient who there is under pregnancy and breast-feeding or a possibility of having become pregnant, or wishes to become pregnant within one month after the scheduled end of an observation period.

Target sample size

45


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigehiko Kitano, M.D.

Organization

Tokyo Women's Medical University School of Medicine

Division name

Diabetes Center Ophthalmology

Zip code


Address

8-1, Kawadacho, Shinjuku-ku, Tokyo,162-8666, Japan

TEL

03-3353-8111

Email

katagiri@dmc.twmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Makiko Katagiri, M.D.

Organization

Tokyo Women's Medical University School of Medicine

Division name

Diabetes Center Ophthalmology

Zip code


Address

8-1, Kawadacho, Shinjuku-ku, Tokyo,162-8666, Japan

TEL

03-3353-8111

Homepage URL


Email

katagiri@dmc.twmu.ac.jp


Sponsor or person

Institute

Tokyo Women's Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Nihon University Itabashi Hospital

Name of secondary funder(s)

None


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

東京女子医科大学 糖尿病センター 眼科(東京都)
日本大学医学部附属板橋病院 眼科(東京都)


Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 10 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

Enrolling by invitation

Date of protocol fixation

2013 Year 03 Month 04 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 10 Day

Last follow-up date

2016 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

2013 Year 06 Month 09 Day

Last modified on

2015 Year 07 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012770


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name