UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Availability of DR-1 on the assessment of tear film on the ocular surface
Title of the study (Brief title)	DR-1 on the assessment of tear film
Region	Japan

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

Objectives
Narrative objectives1	To investigate the efficiency of DR-1 to dry eye in the eyes with soft contact lens
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	DR-1
Key secondary outcomes	Dry eye questionnaire Tear break up time Functional visual acuity

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	soft contact lens users
Key exclusion criteria	patients undergone ophthalmic surgery within 6 months patients with lacrimal punctal plugs patients with severe systemic diseases
Target sample size	30

Research contact person
Name of lead principal investigator	Minako Kaido
Organization	Wada Eye Clinic
Division name	ophthalmology
Address	Houjyou 2578 Tateyama-shi Chiba japan
TEL	0470-22-6311
Email	fwiw1193@mb.infoweb.ne.jp

Public contact
Name of contact person	Minako Kaido
Organization	Wada Eye Clinic
Division name	ophthalmology
Address	Houjyou 2578 Tateyama-shi Chiba japan
TEL	0470-22-6311
Homepage URL
Email	fwiw1193@mb.infoweb.ne.jp

Sponsor
Institute	Wada Eye Clinic
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 04 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 04 Month 28 Day
Last follow-up date	2017 Year 07 Month 31 Day
Date of closure to data entry	2017 Year 08 Month 20 Day
Date trial data considered complete	2017 Year 08 Month 20 Day
Date analysis concluded	2017 Year 10 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	not applicable

Management information
Registered date	2017 Year 04 Month 27 Day
Last modified on	2017 Year 11 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031132