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
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
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
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
