UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019738 |
|---|---|
| Receipt number | R000022781 |
| Scientific Title | Effect of rebamipide in soft contact lens patients with dry eyes. |
| Date of disclosure of the study information | 2015/11/11 |
| Last modified on | 2016/07/01 17:55:06 |
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Basic information
Public title
Effect of rebamipide in soft contact lens patients with dry eyes.
Acronym
Effect of rebamipide in soft contact lens patients with dry eyes.
Scientific Title
Effect of rebamipide in soft contact lens patients with dry eyes.
Scientific Title:Acronym
Effect of rebamipide in soft contact lens patients with dry eyes.
Region
| Japan |
Condition
Condition
dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examined subjective symptoms, objective signs and inflammatory cytokines for dry eye patients with contact lens.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
subjective symptoms after 1 month
Key secondary outcomes
Examination of dry eye
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-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
Eye drop of rebamipide
1 month
4 times per a day
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
Dry eye patient with soft contact lens.
Key exclusion criteria
Patient with drug allergy.
Patient with allergic conjunctivitis or allergic rhinitis.
Patient with more than 2 points for examination of corneal fluorescein staining score.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Igarashi |
Organization
Nippon medical school hospital
Division name
Ophthalmology
Zip code
Address
1-1-5 Sendagi, Bunkyoku, Tokyo
TEL
03-3822-2131
tutomu@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Igarashi |
Organization
Nippon Medical School Hospital
Division name
Ophthalmology
Zip code
Address
1-1-5 Sendagi, Bunkyoku, Tokyo
TEL
03-3822-2131
Homepage URL
tutomu@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yaguchi Eye Clinic
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
| 2015 | Year | 11 | Month | 11 | 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
| 2015 | Year | 11 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 11 | 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
| 2015 | Year | 11 | Month | 10 | Day |
Last modified on
| 2016 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022781
