UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022629 |
|---|---|
| Receipt number | R000026088 |
| Scientific Title | Clinical Pharmacological Study to Investigate the Effects of Mucosta Ophthalmic Suspension UD2% on Ocular Surface Cells in Patients with Dry Eye |
| Date of disclosure of the study information | 2016/06/10 |
| Last modified on | 2017/12/26 11:01:53 |
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Basic information
Public title
Clinical Pharmacological Study to Investigate the Effects of Mucosta Ophthalmic Suspension UD2% on Ocular Surface Cells in Patients with Dry Eye
Acronym
Clinical pharmacological study of Mucosta Ophthalmic Suspension UD2% for Patients with Dry Eye
Scientific Title
Clinical Pharmacological Study to Investigate the Effects of Mucosta Ophthalmic Suspension UD2% on Ocular Surface Cells in Patients with Dry Eye
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Dogru Murat |
Organization
Tokyo Dental College Ichikawa General Hospital
Division name
Department of Ophthalmology
Zip code
Address
5-11-13 Sugano, Ichikawa, Chiba, Japan
TEL
+81-047-322-0151
info@eyebank.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dogru Murat |
Organization
Tokyo Dental College Ichikawa General Hospital
Division name
Department of Ophthalmology
Zip code
Address
5-11-13 Sugano, Ichikawa, Chiba, Japan
TEL
+81-047-322-0151
Homepage URL
info@eyebank.or.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
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
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 |
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
| 2016 | Year | 05 | Month | 12 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026088
