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
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
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
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
