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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031169
Receipt No. R000035369
Scientific Title Evaluation of sense of commercial eye drops for contact lens wearers
Date of disclosure of the study information 2018/02/07
Last modified on 2018/03/07

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Basic information
Public title Evaluation of sense of commercial eye drops for contact lens wearers
Acronym Evaluation of sense of commercial eye drops for contact lens wearers
Scientific Title Evaluation of sense of commercial eye drops for contact lens wearers
Scientific Title:Acronym Evaluation of sense of commercial eye drops for contact lens wearers
Region
Japan

Condition
Condition Contact lens wearers
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the refreshing feeling of commercial eye drops for contact lens wearers which have cooling sensation.
Basic objectives2 Others
Basic objectives -Others None
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Four eye drops will be tested. Instill one drop each to both eyes with wearing contact lenses, and then answer to the questionnaire. (Take interval of 30 minutes for each eye drops)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Four eye drops will be tested for one time each.
(Instill one drop each to both eyes, and test another eye drops after 30 minutes in the same way.)
a) Eye drops P: New Mytear CL Cool - a
b) Eye drops Q: New Mytear CL Cool Hi-a
c) Eye Drops R: New Mytear CL Cool Ice Crush
d) Eye drops S: First Mytear CL-B
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
60 years-old >=
Gender Male and Female
Key inclusion criteria 1) Those who wearing contact lenses.
2) Those who have no disease in the eyes.
3) Those who purchase commercial cool type eye drops for contact lens wearers by themselves.
Key exclusion criteria 1) Those who are not wearing contact lenses.
2) Those who have not purchased commercial eye drops.
3) Those who mainly use non-cool type eye drops for contact lens wearers.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitosh Adachi
Organization Senju Pharmaceutical Co., Ltd
Division name Nonprescription Drug Division
Zip code
Address 2-5-8 Hiranomachi, Chuo-ku, Osaka Japan
TEL 06-6201-9615
Email hitoshi-adachi@senju.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyoshi Soma
Organization Senju Pharmaceutical Co., Ltd
Division name Nonprescription Drug Division Marketing Third Group
Zip code
Address 2-5-8 Hiranomachi, Chuo-ku, Osaka Japan
TEL 06-6201-9615
Homepage URL
Email n-souma@senju.co.jp

Sponsor
Institute Senju Pharmaceutical Co., Ltd
Institute
Department

Funding Source
Organization Senju Pharmaceutical Co., Ltd
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
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

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 07 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
2018 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 05 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
2018 Year 02 Month 06 Day
Last modified on
2018 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035369

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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