UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of sense of commercial eye drops for contact lens wearers
Title of the study (Brief title)	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	Hitosh Adachi
Organization	Senju Pharmaceutical Co., Ltd
Division name	Nonprescription Drug Division
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	Nobuyoshi Soma
Organization	Senju Pharmaceutical Co., Ltd
Division name	Nonprescription Drug Division Marketing Third Group
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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