UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019009 |
|---|---|
| Receipt number | 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 10:34:45 |
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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
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
a-nagai@apoplus.co.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021990
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