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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000001559
Receipt No. R000001886
Scientific Title A clinical study of therapeutic use of silicone hydrogel contact lenses in patients with ocular surface diseases
Date of disclosure of the study information 2009/02/01
Last modified on 2008/12/09

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Basic information
Public title A clinical study of therapeutic use of silicone hydrogel contact lenses in patients with ocular surface diseases
Acronym Therapeutic use of silicone hydrogel contact lenses
Scientific Title A clinical study of therapeutic use of silicone hydrogel contact lenses in patients with ocular surface diseases
Scientific Title:Acronym Therapeutic use of silicone hydrogel contact lenses
Region
Japan

Condition
Condition ocular surface diseases
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to determine the safety and efficacy of the silicone hydrogel contact lens in the management of ocular surface diseases.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of ocular surface damages and symptom (Ocular surface diseases index)
Complications
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients with bilateral or unilateral ocular surface diseases who need to were therapeutic contact lenses.
Key exclusion criteria The patients who are difficult to were contact lenses.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Hori
Organization Osaka University
Division name Ophthalmology
Zip code
Address 2-2 Yamadaoka #E7, Suita, Osaka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University
Division name Ophthalmology
Zip code
Address
TEL
Homepage URL
Email hori@ophthal.med.osaka-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Osaka University Medical School
Institute
Department

Funding Source
Organization The Japanese Ministry of Education, Culture, Sports Science and Technology
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
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
2009 Year 02 Month 01 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
in submitting IRB
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 Preinitiation
Date of protocol fixation
2009 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information in submitting IRB

Management information
Registered date
2008 Year 12 Month 09 Day
Last modified on
2008 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001886

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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