UMIN-CTR Clinical Trial

Public title

Clinical efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctivitis

Acronym

Clinical efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctivitis

Scientific Title

Clinical efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctivitis

Scientific Title:Acronym

Clinical efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctivitis

Region

Japan

Condition

Allergic conjunctivitis

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate clinical efficacy of epinastine hydrochloride ophthalmic solution in the patients wearing contact lenses with allergic conjunctivitis

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Change in scores of subjective symptoms
Change in scores of objective findings

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 8 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 who has a positive result of type I allergy test by immuno-cap rapid
2)The planned patient who wears the contact lenses of the same product during a study

Key exclusion criteria

1)The patient at the start of the test, it is determined that the continuously during the test period should not wear contact lenses
2)Females who are or may be pregnant, or lactating
3)Patients with a history of hypersensitivity to study drug or test material
4)Patient who the investigator considers ineligible for enrolment

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Hiroshi Kamezawa

Organization

Kamezawa EYE CLINIC

Division name

Kamezawa EYE CLINIC

Zip code

Address

Clinic Building 3 floor, 3-8-3 Bessho, Minami-ku, Yokohama

TEL

045-731-1113

Email

kamezawa-ganka@pearl.ocn.ne.jp

Name of contact person

1st name
Middle name
Last name	Hiroshi Kamezawa

Organization

Kamezawa EYE CLINIC

Division name

Kamezawa EYE CLINIC

Zip code

Address

Clinic Building 3 floor, 3-8-3 Bessho, Minami-ku, Yokohama

TEL

045-731-1113

Homepage URL

Email

kamezawa-ganka@pearl.ocn.ne.jp

Institute

Kamezawa EYE CLINIC

Institute

Department

Personal name

Organization

Santen Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

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

02

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

50 patients with allergic conjunctivitis wearing CL were instilled for 8 weeks with BAK-free epinastine hydrochloride ophthalmic solution, and clinical efficacy and safety were examined.
Itchy eye, conjunctival hyperemia and staining score of kerato and conjunctival membrane were significantly improved by ocular instillation on CL wearing, which results were similar to the previous reports. Ocular instillation on CL wearing highly satisfied the patients with allergic conjunctivitis, which resulted in the CL wearing time extended to the same level as before the morbidity.Furthermore, eye drop instillation on CL wearing didn't have harmful effects on CL fitting, there were no adverse events such as corneal and conjunctival epithelial disorder, which suggested no concern in safety.
From the above results, it can be expected that ocular instillation on CL wearing with epinastine hydrochloride ophthalmic solution can be a treatment for improving the symptoms and clinical findings of allergic conjunctivitis without impairing safety and increasing patient satisfaction.

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

12

Month

17

Day

Date of IRB

Anticipated trial start date

2015

Year

02

Month

01

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

01

Month

23

Day

Last modified on

2017

Year

08

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018933