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

Scientific Title:Acronym

Evaluation of efficacy and safety of Mucosta ophthalmic suspension UD2% in dry eye patients complicated with glaucoma.

Region

Japan

Condition

Dry eye

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

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

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

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 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

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name