UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028179 |
|---|---|
| Receipt number | R000032224 |
| Scientific Title | Effect on the Tear Film Lipid Layer after Liposomal Spray in the Dry Eyes with Meibomian Gland Dysfunction |
| Date of disclosure of the study information | 2017/08/21 |
| Last modified on | 2017/07/11 15:13:34 |
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Basic information
Public title
Effect on the Tear Film Lipid Layer after Liposomal Spray in the Dry Eyes with Meibomian Gland Dysfunction
Acronym
Liposomal Spray and Tear Film Lpid Layer
Scientific Title
Effect on the Tear Film Lipid Layer after Liposomal Spray in the Dry Eyes with Meibomian Gland Dysfunction
Scientific Title:Acronym
Liposomal Spray and Tear Film Lpid Layer
Region
| Japan |
Condition
Condition
Dry eyes with meibomian gland dysfuncion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of liposlmal spray applicaion on the tear film lipid layer in dry eyes with meibomian gland dysfucntion (MGD).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time course of lipid layer thickness after liposomal spray application
Key secondary outcomes
Tear interferometric pattern
Non invasive tear film breakup time
Tear meniscus height
Blink rate
Subjective Symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Single application of liposomal spray
Interventions/Control_2
Single application of normal saline
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
Patients diagnosed as dry eye by 2006 diagnostic criteria
Patients diagnosed as MGD by 2010 diagnostic criteria
Tear film lipid layer thickness is less than 75nm by LipiView
Key exclusion criteria
Subjects without written informed consent
Obvious ocular surface or eyelid disease
Contact lens wear
Punctal plug insertion
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Reiko Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
Address
626-11, Minaminakano. Minuma-ku, Saitama City
TEL
048-686-5588
ritoh@za2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Reiko Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
Address
626-11, Minaminakano. Minuma-ku, Saitama City
TEL
048-686-5588
Homepage URL
ritoh@za2.so-net.ne.jp
Sponsor or person
Institute
Itoh Clinic
Institute
Department
Personal name
Funding Source
Organization
Lid and Meibomian Gland Dysfunction Working Group
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
| 2017 | Year | 08 | Month | 21 | 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
| 2017 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 21 | 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
| 2017 | Year | 07 | Month | 11 | Day |
Last modified on
| 2017 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032224
