UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003829 |
|---|---|
| Receipt number | R000004618 |
| Scientific Title | Efficacy and safety of long-term use of topical corticosteroids following corneal transplantation |
| Date of disclosure of the study information | 2010/07/01 |
| Last modified on | 2012/06/27 16:24:27 |
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Basic information
Public title
Efficacy and safety of long-term use of topical corticosteroids following corneal transplantation
Acronym
Long-term use of topical steroids following corneal transplantation
Scientific Title
Efficacy and safety of long-term use of topical corticosteroids following corneal transplantation
Scientific Title:Acronym
Long-term use of topical steroids following corneal transplantation
Region
| Japan |
Condition
Condition
Following penetrating keratoplasty
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study efficacy and safety of long-term use of low dose topical corticosteroids following penetrating keratoplasty
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Development of immunological rejection during the study period
Key secondary outcomes
Development of local complications associated with the use of topical corticosteroids
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
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
use of topical low-dose corticosteroids (0.1% fluoromethorone) three times a day
Interventions/Control_2
discontinuation of topical corticosteroids
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eyes that had penetrating keratoplasty for more than 1 years ago, and the grafts remain clear with the use of topical corticosteroids
Key exclusion criteria
active ocular infection
eyes that need topical corticosteroids for uveitis or ocular allergy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Shimazaki |
Organization
Tokyo Dental College, Ichikawa General Hospital
Division name
Ophthalmology
Zip code
Address
5-11-13 Sugano, Ichikawa, Chiba, Japan
TEL
0473-22-0151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Shimazaki |
Organization
Tokyo Dental College, Ichikawa General Hospital
Division name
Ophthalmology
Zip code
Address
5-11-13 Sugano, Ichikawa, Chiba, Japan
TEL
0473-22-0151
Homepage URL
http://www.tdc-eyecom
jun@eyebank.or.jp
Sponsor or person
Institute
Department of Ophthalmology, Tokyo Dental College, Ichikawa General Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Tokyo Dental College, Ichikawa General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
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
東京歯科大学市川総合病院（千葉）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Prolonged use of 0.1% fluorometholone was beneficial for the prevention of rejection after penetrating keratoplasty. Because no adverse consequences were noted, we recommend continuing use of the low-dose corticosteroids, even in non.high-risk cases
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
| 2010 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 27 | Day |
Last modified on
| 2012 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004618
