UMIN-CTR Clinical Trial

Public title

Efficacy of epinastine hydrochloride ophthalmic solution in the patients with allergic conjunctivitis after treating with olopatadine hydrochloride ophthalmic solution.

Acronym

Efficacy of epinastine hydrochloride ophthalmic solution in the patients with allergic conjunctivitis.

Scientific Title

Efficacy of epinastine hydrochloride ophthalmic solution in the patients with allergic conjunctivitis after treating with olopatadine hydrochloride ophthalmic solution.

Scientific Title:Acronym

Efficacy of epinastine hydrochloride ophthalmic solution in the patients with allergic conjunctivitis.

Region

Japan

Condition

Allergic conjunctivitis

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Clinical evaluation of epinastine hydrochloride ophthalmic solution in the patients with allergic conjunctivitis insufficiently controlled with olopatadine hydrochloride ophthalmic solution.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Percentage of patients with improved symptoms, Change in scores of subjective symptoms(at visits), Change in scores of objective findings(at visits)

Key secondary outcomes

Change in scores of subjective symptoms(in patient diary), compliance status, change of value in questionnaire items

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Epinastine hydrochloride ophthalmic solution, apply 1 drop a time, 4 times daily, in the both eyes.

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

Age-lower limit

6

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients aged 6 years or older
2)Patients diagnosed as allergic conjunctivitis in the both eyes.
3)Patients with moderate or severe ocular pruritus and switching medication after treated with olopatadine hydrochloride ophthalmic solution at the time of informed consent, or requiring switching drugs judged by study doctor.

Key exclusion criteria

1) Patients given immunotherapy (hyposensitization therapy, modulated therapy).
2) Patients with ocular pruritus and hyperemia caused by a disease other than allergic conjunctivitis which will influence drug evaluation.
3) Patients with a history of atopic keratoconjunctivitis, spring catarrh, giant papillary conjunctivitis, corneal herpes, recurrent corneal erosion caused by the frequent occurrence of corneal injury or dry eye.
4) Patients with surgical history in the internal eye (including laser therapy) within 90 days prior to initiation of the clinical research.
5) Patients with possibility taking medicines (including anti-allergic agent, immunosuppressive drugs and adrenal cortex steroid except eye drops) which affect the efficacy of study drug. However, the use of ophthalmic solutions of adrenal cortex steroid is admitted as needed if there is no improvement in symptoms.
6) Females who are or may be pregnant, or lactating
7) Patients with a history of hypersensitivity to study drug or test material.
8) Patients with severe complications (such as immediate hospitalized care is required) which are identified inappropriate for safety reason.
9) Patients who have any other reasons that causes the study doctor to deem a subject unsuitable for the study.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Kenichi Mihara

Organization

Mihara eye clinic,
medical corporation houjinkai

Division name

Mihara eye clinic,

Zip code

Address

2-309 Shintokuda, Kannabe, Fukuyama, Hiroshima

TEL

084-960-5525

Email

mihara.eye@fmed.jp

Name of contact person

1st name
Middle name
Last name	Kenichi Mihara

Organization

Mihara eye clinic,

Division name

Mihara eye clinic,

Zip code

Address

2-309 Shintokuda, Kannabe, Fukuyama, Hiroshima

TEL

084-960-5525

Homepage URL

Email

mihara.eye@fmed.jp

Institute

Mihara eye clinic,
medical corporation houjinkai

Institute

Department

Personal name

Organization

Santen 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

医療法人社団豊仁会　みはら眼科(広島県)

Date of disclosure of the study information

2015

Year

01

Month

30

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

10

Month

06

Day

Date of IRB

Anticipated trial start date

2014

Year

12

Month

12

Day

Last follow-up date

2015

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

01

Month

20

Day

Last modified on

2016

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=R000018881