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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014423
Receipt No. R000016782
Scientific Title Study of Matrix Metalloproteinase (MMP)-9 expressions in ocular surface disorders using dry eye diagnostic kit InflammaDry
Date of disclosure of the study information 2014/07/01
Last modified on 2014/06/30

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Basic information
Public title Study of Matrix Metalloproteinase (MMP)-9 expressions in ocular surface disorders using dry eye diagnostic kit InflammaDry
Acronym Study of MMP-9 expressions in ocular surface disorders using InflammaDry
Scientific Title Study of Matrix Metalloproteinase (MMP)-9 expressions in ocular surface disorders using dry eye diagnostic kit InflammaDry
Scientific Title:Acronym Study of MMP-9 expressions in ocular surface disorders using InflammaDry
Region
Japan

Condition
Condition Infectious keratitis, non-infectious corneal ulcer, Sjogren syndrome, meibomian gland dysfunction, etc.
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Diagnosis of dry eye is based on 1. patient's symptom, 2. abnormalities of tears, and 3. disorders in the epithelium of cornea and conjunctiva. Recently, diagnostic kit of dry eye (InflammaDry), which is able to detect MMP(matrix metalloproteinase)-9, was approved by United States FDA. MMP-9 is expressed not only in dry eye, but also in various ocular surface diseases, such as severe allergic conjunctivitis, corneal ulcer, and chemical burn. Because InflammaDry is able to detect MMP-9 rapidly, the object of this study is to determine the efficacy of InflammaDry in various ocular surface disorders.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Detection of MMP-9 using InflammaDry
Key secondary outcomes Findings of slitlamp microscopy in each cases

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 The case is tested only once, at the first visit.
Interventions/Control_2
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) Patients who are over 20 years-old.
2) Patients who have ocular surface disorders mentioned previously.
3) Patients who are visiting the clinic
4) Patients who are able to obtain informed consent.
Key exclusion criteria 1) Patients who may have the possibility to have contagious diseases.
2) Patients who are considered to be unsuitable for various reasons.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tohru Sakimoto
Organization Nihon University School of Medicine
Division name Ophthalmology
Zip code
Address 30-1 Ooyaguchikamimachi, Itabashi-ku
TEL 03-3972-8111(2531)
Email torusaki@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tohru Sakimoto
Organization Nihon University School of Medicine
Division name Ophthalmology
Zip code
Address 30-1 Ooyaguchikamimachi, Itabashi-ku
TEL 03-3972-8111(2531)
Homepage URL
Email torusaki@gmail.com

Sponsor
Institute Department of Ophthalmology, Nihon University School of Medicine
Institute
Department

Funding Source
Organization Department of Ophthalmology, Nihon University School of Medicine
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
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
2014 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 Enrolling by invitation
Date of protocol fixation
2014 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 05 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
2014 Year 06 Month 30 Day
Last modified on
2014 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016782

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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