UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan

Condition

Perennial 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 perennial 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

Improvement rate of pruritus and hyperemia
Change in scores of subjective symptoms, change in scores of objective findings, change of value in patient diary and questionnaire items

Key secondary outcomes

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, for 4 weeks

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

16

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients aged 16 years or older
2)Patients diagnosed as perennial allergic conjunctivitis in the both eyes.
3)Patients with moderate or severe ocular pruritus and switching medication after treated with olopatadine hydrochloride ophthalmic solution for two weeks or more at the time of informed consent.

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
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	Yoshitaka Oka

Organization

Oka ophthalmology clinic, incorporated medical institution

Division name

Oka ophthalmology clinic, incorporated medical institution

Zip code

Address

364-2 Kawazu, Iizuka, Fukuoka

TEL

0948-22-5155

Email

mail@okaganka.com

Name of contact person

1st name
Middle name
Last name	Yoshitaka Oka

Organization

Oka ophthalmology clinic, incorporated medical institution

Division name

Oka ophthalmology clinic, incorporated medical institution

Zip code

Address

364-2 Kawazu, Iizuka, Fukuoka

TEL

0948-22-5155

Homepage URL

Email

mail@okaganka.com

Institute

Oka ophthalmology clinic, incorporated medical institution

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　岡眼科クリニック(福岡県)

Date of disclosure of the study information

2014

Year

12

Month

25

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

[Subjects]
- Fifteen patients diagnosed as perennial allergic conjunctives insufficiently controlled with olopatadine hydrochloride ophthalmic solution. (Patients with moderate or severe ocular pruritus after treated with Patanol). Study Period is 4 weeks , from September 1, 2014 to October 31, 2015 (exclude SAC)

[Observations]
-Subjective symptom and objective finding scores and improvement rate of itching score.IMPROVE when the score at W4 is lower than that of study initiation, WORSEN when the score increases, NONE when there is no change.
-Questionnaire after 4weeks : feeling in using the drug and satisfaction level, etc.

[Result]
The itching score was significantly improved after the treatment was changed from olopatadine hydrochloride ophthalmic solution to epinastine hydrochloride ophthalmic solution. Before the treatment change: 2.5 plus or minus 0.5, 4 weeks after the treatment change: 0.9 plus or minus 0.7(P=0.0004) . Regarding subjective itching symptom, 81.8% of 11 patients were IMPROVE, 18.2% were N0 CHANGE and 0% was GET WORSE. Conjunctival injection score (eyelid + eyeball) was significantly decreased 4 weeks after the treatment was changed. Before the treatment change: 2.3 plus or minus 1.1 , 4 weeks after the treatment change: 1.5 plus or minus 0.7(P=0.0251). The survey on the patients shows satisfaction with the effect on relieving itching, quick acting and a feeling in using the drug.

[Conclusion]
It was suggested from the study that the changing treatment to epinastine hydrochloride ophthalmic solution with patients diagnosed as perennial allergic conjunctives who were insufficiently controlled with olopatadine hydrochloride ophthalmic solution possibly improved allergic symptoms and was effective on the patients.

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

08

Month

13

Day

Date of IRB

Anticipated trial start date

2014

Year

11

Month

01

Day

Last follow-up date

2015

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

12

Month

22

Day

Last modified on

2016

Year

03

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018634