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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002200
Receipt No. R000002704
Scientific Title Oral pilocarpine for treatment in patients with xerotic keratoconjunctivitis
Date of disclosure of the study information 2009/09/01
Last modified on 2009/07/14

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Basic information
Public title Oral pilocarpine for treatment in patients with xerotic keratoconjunctivitis
Acronym Oral Pilocarpine for treatment in patients with dry eye
Scientific Title Oral pilocarpine for treatment in patients with xerotic keratoconjunctivitis
Scientific Title:Acronym Oral Pilocarpine for treatment in patients with dry eye
Region
Japan

Condition
Condition xerotic conjunctivits
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The chief therapy of dry eye is eye drop.But,we face the patients who have the difficulty of using a eye drop for dry eye.Oral pilocarpine may rescue the patients for dry eye who feel the abnormality with eye drops.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A complainment of dry eye
The tear secretion
Break up time of the tear
Keratocounjunctive epithlium disturbance
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral pilocarpine
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
90 years-old >=
Gender Male and Female
Key inclusion criteria The people who has the complainment of dryness, watering,eye fatigue.
The people who has the abnormality of tear
The people who has the keratoconjunctive epithelium disturbance
Key exclusion criteria Diabetic mellitus
The people who wear the contact lens
The patients who take a therapy of eye drops for glaucoma
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Naito
Organization The University of TOkushima, School of Medicine
Division name Department of Ophthalmology and Visual neuroscience
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima-city
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The University of TOkushima, School of Medicine
Division name Department of Ophthalmology and Visual neuroscience
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Ophthalmology and Visual neuroscience,The University of Tokushima, School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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 09 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
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 07 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 14 Day
Last modified on
2009 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002704

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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