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


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 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


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

Value
https://center6.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