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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000008308
Receipt No. R000009784
Scientific Title Evaluation of efficacy and safety of rebamipide ophthalmic solution for dry eye after surgery of Diabetic Retinopathy
Date of disclosure of the study information 2012/07/01
Last modified on 2012/06/30

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Basic information
Public title Evaluation of efficacy and safety of rebamipide ophthalmic solution for dry eye after surgery of Diabetic Retinopathy
Acronym Efficacy of rebamipide for dry eye after surgery of Diabetic Retinopathy
Scientific Title Evaluation of efficacy and safety of rebamipide ophthalmic solution for dry eye after surgery of Diabetic Retinopathy
Scientific Title:Acronym Efficacy of rebamipide for dry eye after surgery of Diabetic Retinopathy
Region
Japan

Condition
Condition Patients with dry eye after surgery of Diabetic Retinopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and saftety of rebamipide for dry eye after surgery of Diabetic Retinopathy compared with hyaluronic acid
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Fluorescein corneal staining score
Key secondary outcomes Tear film breakup time, Schirmer test(I), Questionnaire, Aqueous flare

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 Rebamipide ophthalmic solution
Interventions/Control_2 hyaluronic acid 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) Patient scheduled for surgery of Diabetic Retinopathy

2) Patient who have symptom of dry eye (foreign body, drying, glaring, pain, blurring, eyestrain)

3) Patient who meet following conditions,
a) Positive vital dye staining of cornea (Fluorescein, more than 3, maximum=9)
b) Schirmer test (I) <= 5mm or Tear film breakup time <= 5 seconds
Key exclusion criteria 1) Patient who do not consent with this study
2) Patient who is considered to be inappropriate for this study (patient who have high risc ocular disorder like Stevens-Johnson syndrome , women under pregnant or lactation period , allergic history to test drug)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinori Mitamura
Organization Tokushima University Hospital
Division name Ophthalmology
Zip code
Address 2-50-1 kuramoto-cho Tokushima-city
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Mitamura
Organization Tokushima University Hospital
Division name Ophthalmology
Zip code
Address 2-50-1 kuramoto-cho Tokushima-city
TEL
Homepage URL
Email

Sponsor
Institute Tokushima University Hospital
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
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 07 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 Preinitiation
Date of protocol fixation
2012 Year 06 Month 27 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2013 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 06 Month 30 Day
Last modified on
2012 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009784

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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