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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009071
Receipt No. R000010646
Scientific Title Evaluation of efficacy of diquafosol sodium ophthalmic solution and sodium hyaluronate ophthalmic solution on treatment of dry eye (multicenter study).
Date of disclosure of the study information 2012/11/01
Last modified on 2014/11/12

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Basic information
Public title Evaluation of efficacy of diquafosol sodium ophthalmic solution and sodium hyaluronate ophthalmic solution on treatment of dry eye (multicenter study).
Acronym Evaluation of efficacy of diquafosol sodium ophthalmic solution and sodium hyaluronate ophthalmic solution on treatment of dry eye (multicenter study).
Scientific Title Evaluation of efficacy of diquafosol sodium ophthalmic solution and sodium hyaluronate ophthalmic solution on treatment of dry eye (multicenter study).
Scientific Title:Acronym Evaluation of efficacy of diquafosol sodium ophthalmic solution and sodium hyaluronate ophthalmic solution on treatment of dry eye (multicenter study).
Region
Japan

Condition
Condition Dry eye
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To make a comparative review of efficacy, the changes of subjective symptom and safety of diquafosol sodium ophthalmic solution and sodium hyaluronate ophthalmic solution.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Symptoms and Tear film breakup time
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Diquafosol sodium ophthalmic solution
Interventions/Control_2 Sodium hyaluronate ophthalmic solution
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) 20 years old or older.
2) female or male.
3) Schirmer test I below 5 mm in 5 minutes or BUT below 5 seconds.
4)General state score of symptoms is 4 greater, and degree score is 3 greater in at least more than 1 item within ophthalmic symptoms items.
5)Fluorescein staining score less than 3.
Key exclusion criteria 1) Patients who use artificial tears eyedrops within 2 weeks before a study starts.
2) Patients who need to use eyedrops other than test drugs during a study .
3) Patients who have anatomically and functionally abnormal eyelid.
4) Patients who develop allergic conjunctivitis disease requiring treatment when a study starts.
5) Patients who underwent ophthalmic surgery within 3 months before study starts ( however LASIK within 6 months).
6) Patient who have a previous history of treatment intended to become obstructed lacrimal puncta.
7) Patients who have a previous allergy to drugs that they use during a study.
Target sample size 200

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yuichi Ohashi
Organization Ehime University
Division name Department of Ophthalmology
Zip code
Address Shizugawa touonshi, Ehimeken
TEL 089-960-5361
Email ohashi@m.ehime-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Atsushi Shiraishi
Organization Ehime University
Division name Department of Ophthalmology
Zip code
Address Shizugawa touonshi, Ehimeken
TEL 089-960-5361
Homepage URL
Email shiraia@m.ehime-u.ac.jp

Sponsor
Institute Ehime University
Institute
Department

Funding Source
Organization Santen pharmaceutical company
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2012 Year 11 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 Completed
Date of protocol fixation
2012 Year 10 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 09 Day
Last modified on
2014 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010646

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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