UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008427 |
|---|---|
| Receipt number | R000009777 |
| Scientific Title | Evaluation of efficacy of rebamipide ophthalmic suspension in patients with dry eye associated with Sjogren's syndrome. |
| Date of disclosure of the study information | 2012/07/13 |
| Last modified on | 2013/07/26 13:19:16 |
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Basic information
Public title
Evaluation of efficacy of rebamipide ophthalmic suspension in patients with dry eye associated with Sjogren's syndrome.
Acronym
Evaluation of efficacy of rebamipide ophthalmic suspension in patients with dry eye associated with Sjogren's syndrome.
Scientific Title
Evaluation of efficacy of rebamipide ophthalmic suspension in patients with dry eye associated with Sjogren's syndrome.
Scientific Title:Acronym
Evaluation of efficacy of rebamipide ophthalmic suspension in patients with dry eye associated with Sjogren's syndrome.
Region
| Japan |
Condition
Condition
Patients with dry eye associated with Sjogren's syndrome.
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy of rebamipide ophthalmic suspension in dry eye patients associated with Sjogren's syndrome using corneal and conjunctival staining score, dry eye symptom score and tear breakup test as outcome measures.
Quantitative evaluation of the measurement of scattered light intensity of fluorescein tracers with an anterior-segment analysis equipment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Fluorescein corneal staining score.
2.Lissamine green conjunctival staining score.
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%
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
1.20 years old or older(female or male).
2.Patients who are clinically diagnosed as dry eye and Sjogren's syndrome.
3.At the start of study examination,
i)Fluorescein corneal staining score of 3 greater.(9 point full marks)
ii)Lissamine green conjunctival staining score of 3 greater.(6 point full marks)
4.Outpatient or hospitalization.
5.Patients who can obtain written informed consent.
Key exclusion criteria
1.Patients with concomitant anterior eye disease other than dry eye.
2.Patients who have used rebamipide ophthalmic suspension within two weeks prior to the start of the study.
3.Patients who are anticipated to change their eye drop (prescription or OTC medication) during the study.
4.Patients who cannot discontinue use of contact lenses during the study.
5.Patients who inserted punctal plugs or underwent surgical punctal occlusion within one month.
6.Patients who are pregnant, suspected to be pregnant or breastfeeding.
7.Patients who are hypersensitive to the ingredients of the study drug and/or test reagents for this study.
8.Patients who are judged to be ineligible for the study for complications and/or history of systemic disease.
9.Patients who are considered to be inapproriate by the investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuko Kitagawa |
Organization
Kanazawa Medical University
Division name
Department of Ophthalmology
Zip code
Address
1-1 Daigaku, Uchinada, kahoku, Ishikawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuko Kitagawa |
Organization
Kanazawa Medical University
Division name
Department of Ophthalmology
Zip code
Address
1-1 Daigaku, Uchinada, kahoku, Ishikawa
TEL
Homepage URL
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2012 | Year | 07 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 13 | Day |
Last modified on
| 2013 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009777
