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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009930
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Hiroshima University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010694

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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