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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030038
Receipt No. 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

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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
Email 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
Email clinical@santen.co.jp

Sponsor
Institute Santen Pharmaceutical Co., Ltd.
Institute
Department

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
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

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
URL(English) https://upload.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
Registered date File name


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