UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008873 |
|---|---|
| Receipt number | R000010385 |
| Scientific Title | The open label parallel intergroup trial about the influence on the tear fluid osmotic pressure by an instillation therapy to dry eye patients |
| Date of disclosure of the study information | 2012/09/18 |
| Last modified on | 2023/09/16 11:03:55 |
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Basic information
Public title
The open label parallel intergroup trial about the influence on the tear fluid osmotic pressure by an instillation therapy to dry eye patients
Acronym
Influence of the tear fluid osmotic pressure on dry eye's eye drops
Scientific Title
The open label parallel intergroup trial about the influence on the tear fluid osmotic pressure by an instillation therapy to dry eye patients
Scientific Title:Acronym
Influence of the tear fluid osmotic pressure on dry eye's eye drops
Region
| Japan |
Condition
Condition
dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Influence on tear fluid osmotic pressure and inflammatory cytokine by the eye drop to dry eye patients
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
tear fluid osmotic pressure inflammatory cytokine
Key secondary outcomes
fluorescein corneal staining score
lissamine corneal staining score
breaking up time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sodium hyaluronate eye drop
Interventions/Control_2
Rebamipide eye drop
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A patient aged 20 and over (sex unquestioned)
The patient diagnosed as the example of dry eye decision, or the example of doubt based on dry eye diagnostic criteria (2006)
Hospitalization or visitors; unquestioned
The patient by whom consent is got in written form
Key exclusion criteria
The patient who has merged anterior ocular segment diseases except for dry eye
The patient who is using the patient and the steroid, anti-inflammatory agent, and immunosuppressant
The patient by whom change of eye drops (prescription medicine, OTC medicine) is expected from an inspection till the end of trial drug
The patient for contact lens wearing
The patient who has the eye operation history within 12 months
The patient who enforced insertion of a punctal plug, or a surgical punctal closing way within one month
The patient to whom the examination responsibility doctor or the examination assignment doctor judged the participation in this research to be unsuitable
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Takahashi |
Organization
Nippon Medical School
Division name
Ophthalmology
Zip code
Address
1-1-5 Sendagi,Bunkyo-ku,Tokyo
TEL
03-3822-2131
tutomu@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonaga Takase |
Organization
Nippon Medical School
Division name
IRB
Zip code
Address
1-1-5 Sendagi,Bunkyo-ku,Tokyo
TEL
03-3822-2131
Homepage URL
clinicaltrial@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
MHLW
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
| 2012 | Year | 09 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 07 | Day |
Last modified on
| 2023 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010385
