UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008308 |
|---|---|
| Receipt number | 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 09:01:55 |
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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
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
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009784
