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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005340
Receipt No. R000006347
Scientific Title Evaluation of the changes of quantity and quality of tears by instillation of lipid-containing commercial eye drops.
Date of disclosure of the study information 2011/04/01
Last modified on 2013/04/02

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Basic information
Public title Evaluation of the changes of quantity and quality of tears by instillation of lipid-containing commercial eye drops.
Acronym Evaluation of the changes of tears by lipid-containing commercial eye drops.
Scientific Title Evaluation of the changes of quantity and quality of tears by instillation of lipid-containing commercial eye drops.
Scientific Title:Acronym Evaluation of the changes of tears by lipid-containing commercial eye drops.
Region
Japan

Condition
Condition Dry eye
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the changes of quantity and quality of tears by instillation of lipid-containing commercial eye drops.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Tear film breakup time, corneal and conjunctival epithelial damage score, tear meniscus radius, Schirmer test(I), spreading velocity of tear film lipid layer
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Instillation (Systane® Balance )
Interventions/Control_2 Instillation (Dry Aid® EX)
Interventions/Control_3 Instillation (Soft Santear®)
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 1. Normal subject (20 persons) without following 1)-4)
2. Aqueous tear deficient dry eye patients and Short BUT type dry eye patients (30 persons).
3. Aqueous tear deficient dry eye patients with following 1),2) and 4)
4. Short BUT type dry eye patients with following 1) and 3) who have not been responsible for conventional instillation treatment.

1) Symptoms (Visual disturbance, Discomfort)
2) Schirmer test (I) <= 5mm
3) Tear film breakup time <= 5 seconds
4) Positive vital dye staining of cornea and conjunctiva (Fluorescein, Lissamine green)(more than 3, maximum=9)
Key exclusion criteria Anyone who is considered to be inappropriate for this study

(ex. Any allergic history to Systane Balance, Dry Aid&#174; EX and SoftSantear&#174;, women who are under pregnant or lactation period)
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiko Yokoi
Organization Kyoto Prefectural University of Medicine
Division name Department of Ophthalmology
Zip code
Address 465 kajiicho kawaramachidori hirokouji agaru kamigyoku Kyoto city
TEL 075-251-5575
Email

Public contact
Name of contact person
1st name
Middle name
Last name Norihiko Yokoi, Takahiro Kurose
Organization Kyoto Prefectural University of Medicine
Division name Department of Ophthalmology
Zip code
Address 465 kajiicho kawaramachidori hirokouji agaru kamigyoku Kyoto city
TEL 075-251-5578
Homepage URL
Email

Sponsor
Institute Department of Ophthalmology, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 京都府立医科大学附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Terminated
Date of protocol fixation
2011 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2016 Year 04 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
2011 Year 03 Month 29 Day
Last modified on
2013 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006347

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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