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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021320
Receipt No. 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

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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
Institute Tsurumi University
Institute
Department

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
URL(English) https://upload.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


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