UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002200 |
|---|---|
| Receipt number | 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 22:16:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
Department of Ophthalmology and Visual neuroscience,The University of Tokushima, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002704
