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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009670
Receipt No. R000011342
Scientific Title Symptoms, visual function, and mucin expression of eyes with an unstable tear film
Date of disclosure of the study information 2013/01/07
Last modified on 2012/12/30

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Basic information
Public title Symptoms, visual function, and mucin expression of eyes with an unstable tear film
Acronym Characteristics of eyes with an unstable tear film
Scientific Title Symptoms, visual function, and mucin expression of eyes with an unstable tear film
Scientific Title:Acronym Characteristics of eyes with an unstable tear film
Region
Japan

Condition
Condition dry eye syndrome
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate characteristics and alteration of mucin expression of eyes with an unstable tear film.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes symptom, tear function, visual function ,mucin expression
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
99 years-old >=
Gender Male and Female
Key inclusion criteria patients having ocular discomfort associated with dry eye from the dry eye subspecialty outpatient clinic.
Key exclusion criteria Patients with meibomian gland dysfunction, central conjunctivochalasis, blepharitis, ocular allergy, or other ocular surface disease, cotact lens use, punctal plug insertion, and any eye drops use other than artificial tears.
Patients who had undergone ocular surface surgery, including refractive surgery and keratoplasty.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seika Shimazaki-Den
Organization Tokyo Dental College Ichikawa General Hospital
Division name Opthalmology
Zip code
Address 5-11-13, Sugano, Ichikawa, Chiba, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo Dental College Ichikawa General Hospital
Division name Institutional Review Board
Zip code
Address
TEL
Homepage URL
Email dens@tdc.ac.jp

Sponsor
Institute Tokyo Dental College Ichikawa General Hospital
Institute
Department

Funding Source
Organization Department of Ophthanlmology, Tokyo Dental College
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
2013 Year 01 Month 07 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
2006 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2006 Year 08 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 The symptom scores, tear film stability, and visualfunction were significantly worse in eyes with an unstable tear film and aqueous deficient dry eyes compared with the controls. The mRNA expression levels of MUC5AC and MUC16 were significantly lower in eyes with an unstable tear film and aqueous deficient dry eyes compared with the controls.

Management information
Registered date
2012 Year 12 Month 30 Day
Last modified on
2012 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011342

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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