UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020871 |
|---|---|
| Receipt number | R000024072 |
| Scientific Title | Randomized comparison between diquafosol ophthalmic solution versus rebamipide ophthalmic suspension for dry eye after penetrating keratoplasty |
| Date of disclosure of the study information | 2016/02/03 |
| Last modified on | 2016/02/13 17:44:36 |
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Basic information
Public title
Randomized comparison between diquafosol ophthalmic solution versus rebamipide ophthalmic suspension for dry eye after penetrating keratoplasty
Acronym
Ocular surface after penetrating keratoplasty
Scientific Title
Randomized comparison between diquafosol ophthalmic solution versus rebamipide ophthalmic suspension for dry eye after penetrating keratoplasty
Scientific Title:Acronym
Ocular surface after penetrating keratoplasty
Region
| Japan |
Condition
Condition
dry eyes undergoing PK
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare ocular surface between REB and DQS in patients with dry eye after PK.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TBUT, fluorescein score, and DEQS before and after the treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Diquafosol ophthalmic solution: 4 times a day, 4 week period.
Interventions/Control_2
Rebamipide ophthalmic suspension: 4 times a day, 4 week period.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Follow-up period after PK was at least 6 months or more.
Patients with mild to moderate dry eye based on the criteria of Japanese Dry Eye Society, 2006.
Key exclusion criteria
Patients with a prior or present rejection response.
Patients with corneal calcification or infectious keratitis.
Patients with persistent epithelial defect or severe dry eye
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenaga Kobashi |
Organization
University of Kitasato School of Medicine,
Division name
Department of Ophthalmology
Zip code
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa,
TEL
+81-42-778-8464
himon@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidnenaga Kobashi |
Organization
University of Kitasato School of Medicine,
Division name
Department of Ophthalmology
Zip code
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa,
TEL
+81-42-778-8464
Homepage URL
himon@hotmail.co.jp
Sponsor or person
Institute
University of Kitasato School of Medicine,
Institute
Department
Personal name
Funding Source
Organization
University of Kitasato School of Medicine,
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 03 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | 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
| 2016 | Year | 02 | Month | 03 | Day |
Last modified on
| 2016 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024072
