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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019009
Receipt No. R000021990
Scientific Title The multicenter randomized open controlled trials of impact on clinical effect and oxidative stress markers of Mucosta ophthalmic solution that targets the dry eye patients complicated with Sjogren's syndrome
Date of disclosure of the study information 2015/09/14
Last modified on 2018/03/16

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Basic information
Public title The multicenter randomized open controlled trials of impact on clinical effect and oxidative stress markers of Mucosta ophthalmic solution that targets the dry eye patients complicated with Sjogren's syndrome
Acronym The multicenter randomized open controlled trials of impact on clinical effect and oxidative stress markers of Mucosta ophthalmic solution that targets the dry eye patients complicated with Sjogren's syndrome
Scientific Title The multicenter randomized open controlled trials of impact on clinical effect and oxidative stress markers of Mucosta ophthalmic solution that targets the dry eye patients complicated with Sjogren's syndrome
Scientific Title:Acronym The multicenter randomized open controlled trials of impact on clinical effect and oxidative stress markers of Mucosta ophthalmic solution that targets the dry eye patients complicated with Sjogren's syndrome
Region
Japan

Condition
Condition The dry eye patients complicated with Sjogren's syndrome
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Compared with artificial tears the impact on clinical effect and oxidative stress markers of Mucosta ophthalmic solution that targets the dry eye patients complicated with Sjogren's syndrome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fluorescein staining score
Symptoms Tear film breakup time
Oxidative stress markers in tears
The time of data totalization/analysis will be at baseline, after 4 weeks, or at discontinuation.
Key secondary outcomes

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
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Mucosta ophthalmic suspensionUD2%, q.i.d. and Soft Santear, t.d. for 4weeks in both eyes
Interventions/Control_2 Soft Santear, q.i.d. for 4weeks
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. ambulatory care patients
2. Patients who have been diagnosed with dry eye in the 2006 dry eye diagnostic criteria.
3. Screening starting examination, patients with symptoms of eye associated with dry eye is expressed earlier than 12 months.
4. In the eye drops at the start of testing, dry eye-related eye symptoms (foreign body sensation, dryness, eye pain, photophobia, blurred vision, eye strain) of any of the score is greater than or equal to 50mm patient
5. .Patients following conditions are met in 5. instillation start time of inspection
a) score of fluorescein corneal staining is 3 or more (up to 15)
b) score of fluorescein conjunctival staining is 4 or more (up to 18)
6. In the screening at the start of testing, patient corrected visual acuity is greater than or equal to 0.2 in both eyes.
Key exclusion criteria 1.Patients merged the anterior segment of the eye diseases other than dry eye including blepharitis, lagophthalmos, the blepharospasm and iritis.
2.Patients screening at the start of eye drops other than study drug until the time of the study drug instillation Exit from the test patients who cannot stop the use is expected.
3.Patients who cannot discontinue use of contact lenses during the study.
4.Patients punctal plug dropped out within three months of the insert the punctal plug and are patient or eye drops at the start of testing. Patients with a history of surgical punctal closure surgery.
5.Patients with steroid eye drops within two weeks of screening at the start of inspection.
6.Patients within 12 months of the test at the start of the inspection of surgical history of ocular surface.
Patients with intraocular surgical history within three months.
7.Stevens-Johnson syndrome, patients with advanced eye damage due to ocular pemphigoid.
8.Patients with hypersensitivity to test drug ingredients and this testing of the present study drug.
9.Patients who are judged to be ineligible for the study for complications and/or history of systemic disease.
10.Patients with severe conjunctival laxa Grade3
11.Patients who are considered to be inapproriate by the investigators.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Kinosita
Organization Kyoto Prefectural University of Medicine
Division name Department of Frontier Medical Science and Technology for Ophtalmology
Zip code
Address 465 kajii-cho kawaramachi-hirokoji kamigyo-ku Kyoto-city
TEL 075-251-5111
Email shigeruk@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Nagai
Organization APO PLUS STATION Co.,Ltd
Division name Clinical Study Dept. CRO Business Div.
Zip code
Address Front Place Nihonbashi Bldg. 2-14-1, Nohonbashi, Chuo-ku, Tokyo 103-0027 Japan
TEL 03-6386-8800
Homepage URL
Email a-nagai@apoplus.co.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 09 Month 14 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 Completed
Date of protocol fixation
2015 Year 06 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 19 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 09 Month 14 Day
Last modified on
2018 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021990

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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