UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation using in vivo confocal microscopy on ocular surface in patients with dry eye disease related to short tear film breakup time
Acronym	Confocal microscopic findings for dry eye disease related to short BUT
Scientific Title	Evaluation using in vivo confocal microscopy on ocular surface in patients with dry eye disease related to short tear film breakup time
Scientific Title:Acronym	Confocal microscopic findings for dry eye disease related to short BUT
Region	Japan

Condition
Condition	Dry eye disease related to short tear-film breakup time
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate ocular surface condition in dry eye disease related to short tear-film breakup time by in vivo confocal microscopy.
Basic objectives2	Others
Basic objectives -Others	To evaluate whether the results are useful to determine the prediction of therapeutic intervention.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Severity of ocular surface condition (Grading of squamous metaplasia, Density of inflammatory cells and goblet cells, Presence or absence of corneal nerve abnormality)
Key secondary outcomes

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Adult (Over or equal 20 years old) who can be obtained the written informed consent. 2. Subjects Dry eye disease related to short tear-film breakup time.(20 cases) 3. Controls Patients who do not fulfill the criteria for dry eye disease or meibomian gland dysfunction.(20 cases) *Diagnostic criteria for dry eye disease is based on the revised criteria in 2016 by Japanese dry eye disease society.
Key exclusion criteria	1. Difficulty for examination by HRTII-RCM due to the patient's physical and mental condition. 2. Disadvantage by the examination for the patients. 3. No informed consent 4. No ophthalmic surgeries 5. No contact lens wearer 6. No VDT workers more than or equal 4 hours 7. Patients who are not eligible for entry judged by the principal investigators and collaborators in this study.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Eisuke Middle name Last name Shimizu
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Zip code	160-8582
Address	35 Shinanomachi Shinjuku-ku, Tokyo
TEL	0333531211
Email	ophthalmolog1st.acek39@keio.jp

Public contact
Name of contact person	1st name Eisuke Middle name Last name Shimizu
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Zip code	160-8582
Address	35 Shinanomachi Shinjuku-ku, Tokyo
TEL	0333531211
Homepage URL
Email	ophthalmolog1st.acek39@keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Keio University School of Medicine

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical committee Keio University School of Medicine
Address	35 Shinanomachi Shinjuku-ku
Tel	0333531211
Email	med-rinri-jimu@adst.keio.ac.jp

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	2019 Year 02 Month 18 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	Open public recruiting
Date of protocol fixation	2019 Year 01 Month 28 Day
Date of IRB	2019 Year 01 Month 28 Day
Anticipated trial start date	2019 Year 02 Month 15 Day
Last follow-up date	2020 Year 03 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Corneal sensitivity Value of Shirmer test Fluorescein score Rose Bengal or Lissamin green score Symptom questionnaire Evaluation by In vivo laser confocal micoscopy(Heidelberg Retina Tomograph II-Rostock Cornea Module (HRTII-RCM))

Management information
Registered date	2019 Year 02 Month 15 Day
Last modified on	2021 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040885