UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009670 |
|---|---|
| Receipt number | 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 15:55:14 |
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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
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
dens@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College Ichikawa General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011342
