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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019983
Receipt No. R000023073
Scientific Title Effect of Rebamipide and Diquafosol Ophthalmic Suspension on Ocular Surface for Dry Eye After Penetrating Keratoplasty: Randomized Controlled Trials.
Date of disclosure of the study information 2015/11/29
Last modified on 2015/12/05

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Basic information
Public title Effect of Rebamipide and Diquafosol Ophthalmic Suspension on Ocular Surface for Dry Eye After Penetrating Keratoplasty: Randomized Controlled Trials.
Acronym Ocular Surface after Penetrating Keratoplasty
Scientific Title Effect of Rebamipide and Diquafosol Ophthalmic Suspension on Ocular Surface for Dry Eye After Penetrating Keratoplasty: Randomized Controlled Trials.
Scientific Title:Acronym Ocular Surface after Penetrating Keratoplasty
Region
Japan

Condition
Condition Dry Eyes after Penetrating Keratoplasty
Classification by specialty
Ophthalmology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare ocular surface between rebamipide and diquafosol ophthalmic solutions in dry eyes after penetrating keratoplasty.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ocular surface parameters and subjective symptom before and after ophthalmic solutions
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
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 Suspension: 4 times a day during 4 weeks after treatment
Interventions/Control_2 Diquafosol Ophthalmic Suspension: 4 times a day during 4 weeks after treatment
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
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Dry eyes after penetrating keratoplasy.
Key exclusion criteria None
Target sample size 20

Research contact person
Last 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, Sagamihara, Kanagawa, 228-8555, Japan
TEL +81-42-778-9012
Email himon@hotmail.co.jp

Public contact
1st name of contact person
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, Sagamihara, Kanagawa, 228-8555, Japan
TEL +81-42-778-9012
Homepage URL
Email himon@hotmail.co.jp

Sponsor
Institute University of Kitasato School of Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid for Young Scientists (B)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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
2015 Year 11 Month 29 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 07 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 07 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
2015 Year 11 Month 29 Day
Last modified on
2015 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023073

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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