UMIN-CTR Clinical Trial

Public title

The randomized controlled trial on Mucosta ophthalmic suspension UD2% of effect in cataract surgery for dry eye patients

Acronym

The randomized controlled trial on Mucosta ophthalmic suspension UD2% of effect in cataract surgery for dry eye patients

Scientific Title

The randomized controlled trial on Mucosta ophthalmic suspension UD2% of effect in cataract surgery for dry eye patients

Scientific Title:Acronym

The randomized controlled trial on Mucosta ophthalmic suspension UD2% of effect in cataract surgery for dry eye patients

Region

Japan

Condition

Cataract patients with dry eye

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Before surgery either Mucosta ophthalmic suspension UD2% or Soft Santear is given and after the cataract surgery we will compare the dry eye symptoms then examine the effectiveness of Mucosta ophthalmic suspension UD2%.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Primary outcomes

Wavefront aberration
Fluorescein corneal conjunctival staining scores

Key secondary outcomes

Tear film breakup time (BUT)
Tear Meniscus(TMH)
Schirmer test
Symptoms

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Left eye Soft Santear,right eye Mucosta ophtalmic suspension UD2%,one time for one drop,four times a day,for 14 weeks

Interventions/Control_2

Left eye Mucosta ophthalmic suspention UD2%, right eye Soft Santier, one time for one drop,four times a day, for 14 weeks

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Outpatient
2.Patient who plan the cataract surgery of both eyes
3.Patient who are diagnosed with dry eyes or probable dry eye according to the 2006 dry eye diagnostic criteria

Key exclusion criteria

1.Patients complicated with any anterior segment disease other than dry eyes(including blepharitis,
lagophthalmos,blepharospasm,and iritis ) (excluding past histories)
2. Patients unable to discontinue using contact lenses between the time of tests at the time of screening and the end of topical instillation of the study drug.
3. Patients with a lacrimal plug
implanted or patients in whom a lacrimal opening plug dropped off within 3 months before the time of tests at the start of topical instillation.
4. Patients who perform a plan (hope) of the insertion of the Toric IOLs.
5. Patients with a history of ocular surface surgery within 12 months before tests at the start of topical instillation.
6. Patients with a severe eye disorder due to Stevens-Johnson syndrome or ocular pemphigoid.
7. Patients with hypersensitivity to any ingredient of the present study drug or reagent used in the present study.
8. Patients judged by the principal investigator/sub-investigator to be unable to be included in the study due to a previous or concurrent systemic disease.
9. Other patients judged by the principalinvestigator/sub-investigator to be not appropriate for safe implementation of the present study.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Yasushi Inoue

Organization

The Ethical Review Board of Medical Association Ophthalmological Koseikai

Division name

The Ethical Review Board of Medical Association Ophthalmological Koseikai

Zip code

Address

1-14-31,Uno,Tamano-City,Okayama,Japan 706-0011

TEL

0863-31-1030

Email

inoue@oka.urban.ne.jp

Name of contact person

1st name
Middle name
Last name	Asami Nishimura

Organization

QOL RD Co.,Ltd

Division name

Clinical Development Drug Division

Zip code

Address

Front Place Nihonbashi Bldg. 2-14-1, Nohonbashi, Chuo-ku, Tokyo 103-0027 Japan

TEL

03-6386-8803

Homepage URL

Email

jimukyoku@qol-rd.co.jp

Institute

The Ethical Review Board of Medical Association Ophthalmological Koseikai

Institute

Department

Personal name

Organization

Otsuka Pharmaceutical Co.,Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

03

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2014

Year

11

Month

19

Day

Date of IRB

Anticipated trial start date

2014

Year

12

Month

17

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

03

Month

31

Day

Last modified on

2017

Year

01

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019714