UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030038 |
|---|---|
| Receipt number | R000034300 |
| Scientific Title | Exploratory study for dry eye patient satisfaction with treatment |
| Date of disclosure of the study information | 2017/11/20 |
| Last modified on | 2018/05/21 10:48:15 |
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Basic information
Public title
Exploratory study for dry eye patient satisfaction with treatment
Acronym
Exploratory study for dry eye patient satisfaction with treatment
Scientific Title
Exploratory study for dry eye patient satisfaction with treatment
Scientific Title:Acronym
Exploratory study for dry eye patient satisfaction with treatment
Region
| Japan |
Condition
Condition
Dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate degree of satisfaction with treatment for dry eye patients prescribed dry eye therapeutic ophthalmic solution.
Basic objectives2
Others
Basic objectives -Others
Treatment satisfaction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment satisfaction
Factor analysis of satisfaction
Relationship between patient background and ophthalmic findings / symptoms
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
20 years of age or over
Regardless of sex
Diagnosed dry eye and use Diquafosol sodium ophthalmic solution or Sodium hyaluronate ophthalmic solution 0.1% for more than 3 months.
Key exclusion criteria
Having advanced ocular disorder due to ocular pemphigus or Stevens Johnson syndrome
Using a punctal plug and performing a punctal closure procedure
Diquafosol sodium ophthalmic solution and sodium hyaluronate ophthalmic solution are used in combination.
Treated with Rebamipide suspension eye drop
Subject with hypersensitivity to fluorescein
The investigator judges that the subject is ineligible as the study subject.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayo Hashimoto |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs, Medical Affairs, Global R&D
Zip code
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9604
clinical@santen.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Suwaki |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
FOTE Team
Zip code
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9604
Homepage URL
clinical@santen.co.jp
Sponsor or person
Institute
Santen Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit 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
| 2017 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Inclusion for Analysis: 100 cases [20 males,80 females, Age:70.7 plus or minus 11.2, Elapsed time since diagnosis of dry eye: 62.7 plus or minus 35.7 months]
Treatment satisfaction: Very satisfied 10.0%, satisfied 43.0%, normal 44.0%, dissatisfied 3.0%.
Factor analysis of satisfaction [the most important reason for satisfaction]: moisture feeling 29.0%, dryness improvement 19.0%, foreign body sensation improvement 15.0%.
Relationship between patient background and ophthalmic findings / symptoms: No clear correlation was found.
DEQS score: 13.6 plus or minus 13.3, BUT: 3.9 plus or minus 2.3 sec, corneal and conjunctival staining score: 2.2 plus or minus 1.9, LWE with 30.8%, conjunctival relaxation with 29.3%, SLK with 15.7%, Meibomian Gland abnormalities 80.8%.
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
| 2017 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate treatment satisfaction of dry eye
Management information
Registered date
| 2017 | Year | 11 | Month | 20 | Day |
Last modified on
| 2018 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034300
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
