UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012742 |
|---|---|
| Receipt number | 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 14:42:28 |
* 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
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
jun@eyebank.or.jp
Sponsor or person
Institute
Department of Ophthalmology, Tokyo Dental College Ichikawa General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
