UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021320
Receipt number R000024592
Scientific Title Efficacy and Safety of Eyebon Eye Wash Solution in Allergic Conjunctivitis after Conjunctival Cedar Pollen Allergen Challenge
Date of disclosure of the study information 2016/03/11
Last modified on 2016/03/28 18:46:32

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Basic information

Public title

Efficacy and Safety of Eyebon Eye Wash Solution in Allergic Conjunctivitis after Conjunctival Cedar Pollen Allergen Challenge

Acronym

Efficacy and Safety of Eyebon Eye Wash Solution in Allergic Conjunctivitis

Scientific Title

Efficacy and Safety of Eyebon Eye Wash Solution in Allergic Conjunctivitis after Conjunctival Cedar Pollen Allergen Challenge

Scientific Title:Acronym

Efficacy and Safety of Eyebon Eye Wash Solution in Allergic Conjunctivitis

Region

Japan


Condition

Condition

allergic conjunctivitis

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the superiority of Eyebon Eye Wash Solution compared to no eye wash in relieving the ocular signs and symptoms associated with allergic conjunctivitis using Japanese cedar pollen after the conjunctival allergen challenge (CAC) test.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

1. Evaluation points
Baseline (10 minutes post qualifying CAC test) and at 1, 5, 10, 15, 20, 30, 45 and 60 minutes after eye washing.
2. Contents of the evaluation(Effectiveness)
(1) Ocular itching
(2) Conjunctival redness
(3) Eyelid swelling
(4) Chemosis
(5) Overall Satisfaction
3. Score
(1) Ocular itching: 0-4
(2) Conjunctival redness: 0-4
(3) Eyelid swelling: 0-3
(4) Chemosis: 0-4

Key secondary outcomes

1. Evaluation points
Baseline (10 minutes post qualifying CAC test) and at 1, 5, 10, 15, 20, 30, 45 and 60 minutes after eye washing.
2. Contents of the evaluation(Safety)
(1)Blood pressure
(2)Pulse measurement
(3)Visual acuity test
(4)Anterior ocular segment and fundus


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Eyebon AL
[Methods]
The eyes were washed for 30 seconds with 5 mL of the eyewash solution using the eye cup for commercial eyewash solutions (eye cup attached to Eyebon AL).

Interventions/Control_2

No Treatment

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

A positive CAC was defined as an itching score of > 2 and a hyperemia score of > 2 in the conjunctival vessel bed in both eyes within 10 (+-1) minutes of receiving the patient's last dose of allergen.

Key exclusion criteria

1. have had a history of allergic hypersensitivity or known hypersensitivity to any compound or excipient of the Eyebon Eye Wash
2. have had the presence of any ocular condition that could affect the patient's safety or study parameters (narrow angle glaucoma requiring medication or laser treatment, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium, or a diagnosis of dry eye).
3. have had a known history of vernal keratoconjunctivitis and/or atopic eratoconjunctivitis;
4. have had an ocular surgical intervention within 3 months prior to study and/or a history of refractive surgery within 6 months prior to study.
5. have had any presence of active ocular infection (bacterial, viral, or fungal) or preauricular lymphadenopathy, or positive history of an ocular herpetic infection at their visits.
6. have had any uncontrolled systemic disease.
7. have had a history of status asthmaticus, a known history of persistent moderate or severe asthma, or a known history of moderate to severe allergic asthmatic reactions to study allergens.
8. have manifested signs or symptoms of clinically active allergic conjunctivitis (defined as the presence of any itching or >1 hyperemia in the conjunctival vessel bed) in either eye at the start visit.
9. be a female who was currently pregnant, nursing, or planning a pregnancy.
10. have used any of the disallowed medications (topical, topical ophthalmic, systemic and/or injectable) during the period indicated before and during the study period, including
*aspirin, aspirin containing products
*H1-antagonist antihistamines (including ocular) and all other anti-allergy therapies including prescription, over-the-counter, homeopathy agents
*all other topical ophthalmic preparations (including tear substitutes) other than study drops
*corticosteroids or mast cell stabilizers
*depot corticosteroids

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Fujishima

Organization

Tsurumi University

Division name

Faculty of Dentistry

Zip code


Address

2-1-3 Tsurumi,Tsurumi-ku, Yokohama-shi, Japan.

TEL

045-580-8599

Email

fujishima117@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Fujishima

Organization

Tsurumi University

Division name

Faculty of Dentistry

Zip code


Address

2-1-3 Tsurumi,Tsurumi-ku, Yokohama-shi, Japan.

TEL

045-580-8599

Homepage URL


Email

fujishima117@gmail.com


Sponsor or person

Institute

Tsurumi University

Institute

Department

Personal name



Funding Source

Organization

KOBAYASHI Pharmaceutical Co.,Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

The Kitasato Institute
Ora Japan, Inc.

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

北里研究所


Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 11 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

The 199th Annual Meeting of the Japanese Ophthalmological Society (2015)

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

2014 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 17 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 03 Month 03 Day

Last modified on

2016 Year 03 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024592


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name