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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010912
Receipt No. 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

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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
Institute Tokyo Women's Medical University School of Medicine
Institute
Department

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
URL(English) https://upload.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


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