UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study for dry eye patient satisfaction with treatment
Title of the study (Brief title)	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	Masayo Hashimoto
Organization	Santen Pharmaceutical Co., Ltd.
Division name	Japan Medical Affairs, Medical Affairs, Global R&D
Address	4-20, Ofukacho, Kita-ku, Osaka
TEL	06-4802-9604
Email	clinical@santen.co.jp

Public contact
Name of contact person	Kazuhisa Suwaki
Organization	Santen Pharmaceutical Co., Ltd.
Division name	FOTE Team
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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%.
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