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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024064
Receipt No. R000027708
Scientific Title Safety and efficacy of 3% diquafosol ophthalmic solution for soft contact lens-related dry eye.
Date of disclosure of the study information 2016/09/16
Last modified on 2018/03/19

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Basic information
Public title Safety and efficacy of 3% diquafosol ophthalmic solution for soft contact lens-related dry eye.
Acronym Safety and efficacy of diquafosol ophthalmic solution for soft contact lens-related dry eye.
Scientific Title Safety and efficacy of 3% diquafosol ophthalmic solution for soft contact lens-related dry eye.
Scientific Title:Acronym Safety and efficacy of diquafosol ophthalmic solution for soft contact lens-related dry eye.
Region
Japan

Condition
Condition Dry eye
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of 3% diquafosol ophthalmic solution for soft contact lens-related dry eye.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety
Tear breakup time
corneal and conjunctival staining
subjective symptoms
contrast sensitivity
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Diquafosol Ophthalmic Solution 3%
Interventions/Control_2 Artificial tears
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria To have dry eye subjective symptoms in both eye
mean Tear break up time is less than 5 sec. or Schirmer I test is less than 5 mm (both eye)
To have corneal and conjunctival staining (both eye)
Key exclusion criteria Patients have administration of eye drops for dry eye or steroid eye drops 14 days before start day of this study.
Patient with an infection eye disease.
Patient has a complication of an eye disease except dry eye. This complication is feared to discourage from evaluation of this study.
Patients with allergy to the ingredients used in the present study.
Target sample size 50

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 Group, Development Management Department, Japan Business
Zip code
Address 4-20, Ofukacho, Kita-ku, Osaka
TEL 06-4802-9337
Email clinical@santen.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiaki Yamada
Organization Santen Pharmaceutical Co., Ltd
Division name Japan Medical Affairs Group, Development Management Department, Japan Business
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 茨城西南医療センター病院/Ibaraki Seinan Medical Center Hospital
土浦協同病院なめがた地域医療センター/Tsuchiura Kyodo General Hospital Namegata District Medical Center

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 16 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
2016 Year 05 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 08 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
2016 Year 09 Month 15 Day
Last modified on
2018 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027708

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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