UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The randomized controlled trial on Mucosta ophthalmic suspension UD2% of effect in cataract surgery for dry eye patients
Title of the study (Brief title)	The randomized controlled trial on Mucosta ophthalmic suspension UD2% of effect in cataract surgery for dry eye patients
Region	Japan

Condition
Condition	Cataract patients with dry eye
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Before surgery either Mucosta ophthalmic suspension UD2% or Soft Santear is given and after the cataract surgery we will compare the dry eye symptoms then examine the effectiveness of Mucosta ophthalmic suspension UD2%.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Wavefront aberration Fluorescein corneal conjunctival staining scores
Key secondary outcomes	Tear film breakup time (BUT) Tear Meniscus(TMH) Schirmer test Symptoms

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Left eye Soft Santear,right eye Mucosta ophtalmic suspension UD2%,one time for one drop,four times a day,for 14 weeks
Interventions/Control_2	Left eye Mucosta ophthalmic suspention UD2%, right eye Soft Santier, one time for one drop,four times a day, for 14 weeks
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.Outpatient 2.Patient who plan the cataract surgery of both eyes 3.Patient who are diagnosed with dry eyes or probable dry eye according to the 2006 dry eye diagnostic criteria
Key exclusion criteria	1.Patients complicated with any anterior segment disease other than dry eyes(including blepharitis, lagophthalmos,blepharospasm,and iritis ) (excluding past histories) 2. Patients unable to discontinue using contact lenses between the time of tests at the time of screening and the end of topical instillation of the study drug. 3. Patients with a lacrimal plug implanted or patients in whom a lacrimal opening plug dropped off within 3 months before the time of tests at the start of topical instillation. 4. Patients who perform a plan (hope) of the insertion of the Toric IOLs. 5. Patients with a history of ocular surface surgery within 12 months before tests at the start of topical instillation. 6. Patients with a severe eye disorder due to Stevens-Johnson syndrome or ocular pemphigoid. 7. Patients with hypersensitivity to any ingredient of the present study drug or reagent used in the present study. 8. Patients judged by the principal investigator/sub-investigator to be unable to be included in the study due to a previous or concurrent systemic disease. 9. Other patients judged by the principalinvestigator/sub-investigator to be not appropriate for safe implementation of the present study.
Target sample size	30

Research contact person
Name of lead principal investigator	Yasushi Inoue
Organization	The Ethical Review Board of Medical Association Ophthalmological Koseikai
Division name	The Ethical Review Board of Medical Association Ophthalmological Koseikai
Address	1-14-31,Uno,Tamano-City,Okayama,Japan 706-0011
TEL	0863-31-1030
Email	inoue@oka.urban.ne.jp

Public contact
Name of contact person	Asami Nishimura
Organization	QOL RD Co.,Ltd
Division name	Clinical Development Drug Division
Address	Front Place Nihonbashi Bldg. 2-14-1, Nohonbashi, Chuo-ku, Tokyo 103-0027 Japan
TEL	03-6386-8803
Homepage URL
Email	jimukyoku@qol-rd.co.jp

Sponsor
Institute	The Ethical Review Board of Medical Association Ophthalmological Koseikai
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

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 19 Day
Anticipated trial start date	2014 Year 12 Month 17 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	2015 Year 03 Month 31 Day
Last modified on	2017 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019714