UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026224
Receipt number R000030124
Scientific Title Efficacy of IOP reduction and safety of Mikeluna combination ophthalmic solution switched from Xalatan 0.005% and Mikelan LA 1%,2% ophthalmic solution.
Date of disclosure of the study information 2017/02/20
Last modified on 2020/02/25 10:13:02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Efficacy of IOP reduction and safety of Mikeluna combination ophthalmic solution switched from Xalatan 0.005% and Mikelan LA 1%,2% ophthalmic solution.

Acronym

Efficacy of IOP reduction and safety of Mikeluna combination ophthalmic solution switched from Xalatan 0.005% and Mikelan LA 1%,2% ophthalmic solution.

Scientific Title

Efficacy of IOP reduction and safety of Mikeluna combination ophthalmic solution switched from Xalatan 0.005% and Mikelan LA 1%,2% ophthalmic solution.

Scientific Title:Acronym

Efficacy of IOP reduction and safety of Mikeluna combination ophthalmic solution switched from Xalatan 0.005% and Mikelan LA 1%,2% ophthalmic solution.

Region

Japan


Condition

Condition

glaucoma or ocular hypertension

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate efficacy of IOP reduction and safety of Mikeluna combination ophthalmic solution switched from Xalatan 0.005% and Mikelan LA 1%,2% ophthalmic solution.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

IOP reduction
Adverse event

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

Switching from Xalatan 0.005% and Milelan LA 1%,2% ophthalmic solution to Mikeluna combination ophthalmic solution

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

glaucoma or ocular hypertension
good adherence before the study initiation

Key exclusion criteria

some corneal abnormality or other diseases which may interfere with accurate IOP measurement
history of glaucoma surgery
contraindicated to Beta blockers

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kenji
Middle name
Last name Inoue

Organization

Inouye Eye Hospital

Division name

Medical office

Zip code

101-0062

Address

4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan

TEL

03-3295-0911

Email

study@inouye-eye.or.jp


Public contact

Name of contact person

1st name Kenji
Middle name
Last name Inoue

Organization

Inouye Eye Hospital

Division name

Medical office

Zip code

1010062

Address

4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan

TEL

03-3295-0911

Homepage URL


Email

academy@inouye-eye.or.jp


Sponsor or person

Institute

Inouye Eye Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

Inouye Eye Hospital ethics committee

Address

4-3 Kanda Surugadai Chiyoda-Tokyo, Japan

Tel

03-3295-0911

Email

academy@inouye-eye.or.jp


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

医療法人社団 済安堂 お茶の水・井上眼科クリニック(東京都)/
Medical Corporation Saiando Ochanomizu Inouye eye clinic


Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 20 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

2017 Year 01 Month 06 Day

Date of IRB

2017 Year 01 Month 07 Day

Anticipated trial start date

2017 Year 01 Month 11 Day

Last follow-up date

2018 Year 09 Month 26 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2020 Year 01 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 02 Month 20 Day

Last modified on

2020 Year 02 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030124


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name