UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010457 |
|---|---|
| Receipt number | R000012221 |
| Scientific Title | Examination of the effect of topical Rebamipide after the vitreous surgery in dry eye patients |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2014/11/02 18:31:13 |
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Basic information
Public title
Examination of the effect of topical Rebamipide after the vitreous surgery in dry eye patients
Acronym
Effect of Rebamipide after the vitreous surgery
Scientific Title
Examination of the effect of topical Rebamipide after the vitreous surgery in dry eye patients
Scientific Title:Acronym
Effect of Rebamipide after the vitreous surgery
Region
| Japan |
Condition
Condition
Dry eye patients underwent vitreous surgery
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of Rebamipide in dry eye patients after vitreous surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Fluorescein corneo-conjunctival staining score
Key secondary outcomes
Photophobia, Misty vision, Asthenopia, Feeling of dryness, Foreign-body sensation, Eye pain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Topical Rebamipide
Interventions/Control_2
No therapy
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
Dry eye patient
Post-non sutuered vitrectomy
Key exclusion criteria
Ocular surface disease other than dry eye
Pregnant or lactating patient
Rebamipide allergy
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kitaoka |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Ophtalmology
Zip code
Address
1-7-1 Sakamoto Nagasaki-city
TEL
095-819-7345
tkitaoka@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Uematsu |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Ophtalmology
Zip code
Address
1-7-1 Sakamoto Nagasaki-city
TEL
095-819-7345
Homepage URL
uematsu-ngs@umin.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences, Department of Ophtalmology
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Graduate School of Biomedical Sciences, Department of Ophtalmology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
長崎大学病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | 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
There was no statistical difference in corneal fluorescein score, subjective symptom score, and tear fluid break up time between the rebamipide group and the control group after vitrectomy.
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
Terminated
Date of protocol fixation
| 2013 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 10 | Day |
Date analysis concluded
| 2014 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 09 | Day |
Last modified on
| 2014 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012221
