UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical Pharmacological Study to Investigate the Effects of Mucosta Ophthalmic Suspension UD2% on Ocular Surface Cells in Patients with Dry Eye
Title of the study (Brief title)	Clinical pharmacological study of Mucosta Ophthalmic Suspension UD2% for Patients with Dry Eye
Region	Japan

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

Objectives
Narrative objectives1	he objective of this study is to clarify the pharmacological action of mucosta ophthalmic suspension UD2% on the mucous membrane function of ocular surface by investigating the status of keratoconjunctival epithelial cell and the goblet cell density in patients with dry eye.
Basic objectives2	Others
Basic objectives -Others	Clinical pharmacological study
Trial characteristics_1
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	-Dry eye-related ocular symptoms score -Cytokine and chemokine levels in tears -Tear film breakup time -Fluorescein corneal staining score -Lissamine green conjunctival staining score -Lid wiper epitheliopathy grading -Corneal sensation -Structural score of conjunctival epithelial cell -Goblet cell density -Corneal epithelial cell density, mean individual epithelial cell area (MIECA )and N/C ratio -Corneal neural density
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Mucosta ophthalmic suspension UD2% Dosage: 1 drop, 4 times daily
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.Patients in whom dry eye has been diagnosed based on "2006 Diagnostic Criteria for Dry Eye" 2.Type of patient: Outpatient 3.At least 20 years of age at the time of informed consent obtained 4.Dry eye-related ocular symptom score of >=2 for either one of foreign body sensation; dryness; photophobia; ocular pain; and blurred vision 5.Patients who meet the following conditions in the same eye 1)Corneal fluorescein staining score of >=3 2)Conjunctival fluorescein staining score of >=4 3)Schirmer's test value of <=5 mm at 5 minutes under anesthesia
Key exclusion criteria	1.Patients with any anterior segment eye disease such as blepharitis, lagophthalmos, blepharospasm, and iritis, except dry eye (Patients with past history of those diseases are acceptable.) 2.Patients to whom any ophthalmic drops (all prescription and OCT drugs included) are not able to be discontinued, or expected to be used from the start of the screening until the end of the study period. (Soft santear is acceptable during the screening period.) 3.Patients who cannot discontinue the use of contact lenses from the start of the screening until the end of the study period 4.Patients with punctal plugs 5.Patients who underwent any surgery on the ocular surface within 12 months or intraocular surgery within 3 months prior to the start of the screening 6.Patients with severe ocular disorder due to Stevens-Johnson syndrome or ocular pemphigoid 7.Patients who are pregnant, lactating, or may be pregnant 8.Patients with hypersensitivity reaction to components of the study drug or test agents used in this study 9.Patients whom investigatoror sub-investigatorconsidered not to be able to include the study because of prior or complicated systemic disease 10.Patients participating in another clinical study or trial 11.Others who areconsidered inappropriate for the study by investigatoror sub-investigator
Target sample size	15

Research contact person
Name of lead principal investigator	Dogru Murat
Organization	Tokyo Dental College Ichikawa General Hospital
Division name	Department of Ophthalmology
Address	5-11-13 Sugano, Ichikawa, Chiba, Japan
TEL	+81-047-322-0151
Email	info@eyebank.or.jp

Public contact
Name of contact person	Dogru Murat
Organization	Tokyo Dental College Ichikawa General Hospital
Division name	Department of Ophthalmology
Address	5-11-13 Sugano, Ichikawa, Chiba, Japan
TEL	+81-047-322-0151
Homepage URL
Email	info@eyebank.or.jp

Sponsor
Institute	Otsuka Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	東京歯科大学　市川総合病院（千葉県）/Tokyo Dental College Ichikawa General Hospital (Chiba Prefecture)

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 12 Day
Anticipated trial start date	2016 Year 06 Month 10 Day
Last follow-up date	2017 Year 03 Month 07 Day
Date of closure to data entry
Date trial data considered complete	2017 Year 05 Month 19 Day
Date analysis concluded

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

Management information
Registered date	2016 Year 06 Month 06 Day
Last modified on	2017 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026088