UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021249 |
|---|---|
| Receipt number | R000003557 |
| Scientific Title | Effect of oral lactoferrin in dry eye disease |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2016/03/08 17:52:30 |
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Basic information
Public title
Effect of oral lactoferrin in dry eye disease
Acronym
oral lactoferrin in dry eye
Scientific Title
Effect of oral lactoferrin in dry eye disease
Scientific Title:Acronym
oral lactoferrin in dry eye
Region
| Japan |
Condition
Condition
dry eye disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of oral lactoferrin in dry eye disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
ocular symptoms, dye staining in ocular surface, Schirmer test I after 1 month of oral lactoferrin
Key secondary outcomes
Visual acuity after 1 month of oral lactoferrin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
oral lactoferrin (300mg/day) for 1 month
Interventions/Control_2
no intervention
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 patients are selected by the definition made by Japanese dry eye society in 2006.
1. Ocular symptoms
2. Abnormality of tear film
(Schirmer I < 5 mm or tear break up time <5 sec)
3. Fluorescein staining score>=3/9
Above 3 points need to be satisfied.
Key exclusion criteria
Patients who has severe ocular inflammation
Patients who has systemic diseases
Patients who cannot accept ocular examination
Patients who had ocular surgery within 6 months
Patients who had lacrimal plug treatment within 1 month
Patients who usually use contact lens
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kawakita |
Organization
Keio University School of Medicine
Division name
Ophthalmology
Zip code
Address
Shinanomachi 35, Shinjuku, Tokyo
TEL
03-3353-1211
kawatetsu@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kawakita |
Organization
Keio University School of Medicine
Division name
Ophthalmology
Zip code
Address
Shinanomachi 35, Shinjuku, Tokyo
TEL
03-3353-1211
Homepage URL
kawatetsu@gmail.com
Sponsor or person
Institute
Department of Ophthalmology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
NRL Pharma Inc.
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
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | 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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 29 | Day |
Last modified on
| 2016 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003557
