UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009438 |
|---|---|
| Receipt number | R000011079 |
| Scientific Title | Effect of Diquafosol Sodium Eye Drops on Tear Film Stability |
| Date of disclosure of the study information | 2012/12/01 |
| Last modified on | 2012/11/29 21:07:32 |
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Basic information
Public title
Effect of Diquafosol Sodium Eye Drops on Tear Film Stability
Acronym
Effect of Diquafosol Sodium Eye Drops on Tear Film Stability
Scientific Title
Effect of Diquafosol Sodium Eye Drops on Tear Film Stability
Scientific Title:Acronym
Effect of Diquafosol Sodium Eye Drops on Tear Film Stability
Region
| Japan |
Condition
Condition
unstable tear film type of dry eye disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of diquafosol sodium eye drops on tear film stability in patients with unstable tear film.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
tear film break-up time, tear secretion, ocular surface damage, tear film stability, subjective symptom
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
diquafosol sodium eye drop
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
1) presence of DED symptoms
2) Schirmers value more than 5 mm
3) BUT equal or less than 5 seconds
4) fluorescein score equal or less than 3 points (9 points maximum).
Key exclusion criteria
Eyes with contact lens wearing, active ocular surface disorders other than DED, history of ocular surgeries, presence of punctual plugs, meibomian gland dysfunction with more than moderate degree of severity, and receiving eye drops other than artificial tears or hyaluronic acid were excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seika Shimazaki-Den |
Organization
Tokyo Dental College
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
047-322-0151
Homepage URL
Sponsor or person
Institute
Tokyo Dental College Ichikawa General Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Dental College Ichikawa General Hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 12 | 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
| 2011 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | 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
Management information
Registered date
| 2012 | Year | 11 | Month | 29 | Day |
Last modified on
| 2012 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011079
