UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012742
Receipt No. R000014889
Scientific Title Randomized comparative clinical trial of diquafosol sodium and Rebamipide eye drops for VDT-related dry eye patients
Date of disclosure of the study information 2014/01/01
Last modified on 2017/01/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Randomized comparative clinical trial of diquafosol sodium and Rebamipide eye drops for VDT-related dry eye patients
Acronym Comparative study for the efficacy of two eye drops in VDT-related dry eye
Scientific Title Randomized comparative clinical trial of diquafosol sodium and Rebamipide eye drops for VDT-related dry eye patients
Scientific Title:Acronym Comparative study for the efficacy of two eye drops in VDT-related dry eye
Region
Japan

Condition
Condition VDT-related dry eye
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study efficacy and safety of two newly developed eye drops, diquafosol and rebamipide, in VDT-related dry eye patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 1 Changes in symptom scores at 4th week
2 Changes in tear-film break-up time (BUT) at 4th week
3 Changes in maximum opening time (MOT) at 4th week
Key secondary outcomes 1 Changes in MOT-BUT difference at 4th week
2 Changes in corneal and conjunctival epithelial damage scores at 4th week
3 Changes in subjective scores, BUT, MOT, BUT-MOT difference, and epithelial damage scores at 2nd and 8th weeks
4 Questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 3% diauafosol sodium eye drops 6 times a day
Interventions/Control_2 2% rebamipide eye drops 4 times a day
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
60 years-old >=
Gender Male and Female
Key inclusion criteria 1) Daily VDT workers (>4 hours a day in average)
2) "definite dry eye" or "dry eye suspects" according to the Japanese dry eye criteria in 2006
3) More than mild subjective symptom score by DEQS (dry eye-related quality of life score)
4) No dry eye eye drops for the last 2 weeks or stably used for more than 2 weeks
Key exclusion criteria 1) Daily contact lens user
2) History of diquafosol or rebamipide uses in the last 1 month prior to the initiation of the study
3) Anatomical or functional abnormalities in the eye (ex. lid closure abnormality)
4) History of ophthalmic surgeries for the last 3 months
5) History of lacrimal punctal plug or occlusion
6) Allergy to diauafosal or rebamipide
7) Other conditions that may influence of the assessment of the study
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Shimazaki
Organization Tokyo Dental College Ichikawa General Hospital
Division name Department of Ophthalmology
Zip code
Address 5-11-13 Sugano, Ichikawa, Chiba
TEL 047-322-0151
Email jun@eyebank.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Shimazaki
Organization Tokyo Dental College Ichikawa General Hospital
Division name Department of Ophthalmology
Zip code
Address 5-11-13 Sugano, Ichikawa, Chiba
TEL 047-322-0151
Homepage URL
Email jun@eyebank.or.jp

Sponsor
Institute Department of Ophthalmology, Tokyo Dental College Ichikawa General Hospital
Institute
Department

Funding Source
Organization Santen Pharmaceutical Co.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Shimazaki Eye Clinic, Ichikawa Shapo Eye Clinic, Iidabashi Eye Clinic, Shinjuku Eye Clinic, Ryogoku Eye Clinic, Smile Eye Clinic
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 東京歯科大学市川総合病院(千葉県)

Other administrative information
Date of disclosure of the study information
2014 Year 01 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 Completed
Date of protocol fixation
2013 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
2016 Year 07 Month 01 Day
Date of closure to data entry
2016 Year 07 Month 31 Day
Date trial data considered complete
2016 Year 08 Month 31 Day
Date analysis concluded
2016 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 01 Month 01 Day
Last modified on
2017 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014889

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.