UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009930 |
|---|---|
| Receipt number | R000010694 |
| Scientific Title | A randomized, parallel group design study evaluating the efficacy and safety of Mucosta ophthalmic suspension UD2% compared to Soft Santear (artificial tear) in dry eye patients complicated with glaucoma. |
| Date of disclosure of the study information | 2013/02/01 |
| Last modified on | 2019/08/05 19:21:22 |
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Basic information
Public title
A randomized, parallel group design study evaluating the efficacy and safety of Mucosta ophthalmic suspension UD2% compared to Soft Santear (artificial tear) in dry eye patients complicated with glaucoma.
Acronym
Evaluation of efficacy and safety of Mucosta ophthalmic suspension UD2% in dry eye patients complicated with glaucoma.
Scientific Title
A randomized, parallel group design study evaluating the efficacy and safety of Mucosta ophthalmic suspension UD2% compared to Soft Santear (artificial tear) in dry eye patients complicated with glaucoma.
Scientific Title:Acronym
Evaluation of efficacy and safety of Mucosta ophthalmic suspension UD2% in dry eye patients complicated with glaucoma.
Region
| Japan |
Condition
Condition
Dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical usefulness of Mucosta ophthalmic suspension UD2% compared to Soft Santear (artificial tear) in dry eye patients complicated with glaucoma in a open-label, randomized, parallel group study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fluorescein cornea staining score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
Interventions/Control_2
Soft Santear
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
Patients with POAG who are treated concomittantly with Travatanz 0.004% and Cosopt.
Patients who met the criteria for Definition and Diagnosis of Dry Eye 2006 in Japan.
Key exclusion criteria
(a)Patients with intraocular pressure greater than the target(Refer to the third edition of glaucoma clinical practice guidelines).
(b)Patients with anterior eye disease(including blepharitis, lagophthalmos, blepharospasm and iritis) other than dry eye.(Except for history)
(c)Patients who had ocular administration of treatment for corneal-conjunctival epithelial disorder or dry eye within two weeks prior to the initiation of the study.
(d)Patients who currently have punctal plugs, have had removal of punctal plug(s) or whose punctal plug(s) fell out within 3 months prior to the initiation of the study, or patients with a history of surgical punctal occlusion.
(e)Patients who cannot suspend the use of contact lenses or who expect to use contact lenses.
(f)Patients who are pregnant, suspected to be pregnant or patients who are breastfeeding.
(g)Patients with hypersensitivity to ingredients of the study drugs and test reagents used in this study.
(h)Patients who are judged by the investigator to be inappropriate for the study because of a past or concurrent systemic disease.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiuchi Yoshiaki |
Organization
Hiroshima University
Division name
Ophthalmology
Zip code
Address
1-2-3 Kasumi Minamiku Hiroshima
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hiroshima University
Division name
Ophthalmology
Zip code
Address
TEL
082-257-5247
Homepage URL
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tsukazaki Hospital
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
| 2013 | Year | 02 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | 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
| 2013 | Year | 02 | Month | 01 | Day |
Last modified on
| 2019 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010694
