UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028492 |
|---|---|
| Receipt number | R000032540 |
| Scientific Title | Evaluation of 0.25% AGN-229666 ophthalmic solution compared to vehicle or olopatadine in the conjunctival allergen challenge (CAC) model of allergic conjunctivitis |
| Date of disclosure of the study information | 2017/08/16 |
| Last modified on | 2019/02/01 16:42:17 |
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Basic information
Public title
Evaluation of 0.25% AGN-229666 ophthalmic solution compared to vehicle or olopatadine in the conjunctival allergen challenge (CAC) model of allergic conjunctivitis
Acronym
Evaluation of 0.25% AGN-229666 ophthalmic solution compared to vehicle or olopatadine in the conjunctival allergen challenge (CAC) model of allergic conjunctivitis
Scientific Title
Evaluation of 0.25% AGN-229666 ophthalmic solution compared to vehicle or olopatadine in the conjunctival allergen challenge (CAC) model of allergic conjunctivitis
Scientific Title:Acronym
Evaluation of 0.25% AGN-229666 ophthalmic solution compared to vehicle or olopatadine in the conjunctival allergen challenge (CAC) model of 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 safety and efficacy of AGN-229666 0.25% versus vehicle of AGN-229666 and olopatadine 0.1% ophthalmic solution for the prevention of allergen-mediated conjunctivitis using the conjunctival allergen challenge (CAC) model.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ocular itching
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
AGN-229666 0.25% (1 drop administered bilaterally at hour 0 of Visits 4 and 5)
Interventions/Control_2
vehicle (1 drop administered bilaterally at hour 0 of Visits 4 and 5)
Interventions/Control_3
olopatadine 0.1% (1 drop administered bilaterally at hour 0 of Visits 4 and 5)
Interventions/Control_4
AGN-229666 0.25% and olopatadine 0.1% (1 drop of AGN-229666 0.25% administered in one eye and 1 drop of olopatadine 0.1% administered in the contralateral eye at hour 0 of Visits 4 and 5)
Interventions/Control_5
AGN-229666 0.25% and vehicle (1 drop of AGN-229666 0.25% administered in one eye and 1 drop of vehicle administered in contralateral eye at hour 0 of Visits 4 and 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
1) Be a male or female, at least 20 years of age
2) Be a Japanese patient living in Japan
3) Have the ability to follow study instructions and likely to complete all required Visits
4) Females of childbearing potential must have a negative urine pregnancy test and must not be breastfeeding.
5) Have a history of allergic conjunctivitis and a positive skin test reaction to Japanese cedar pollen-specific allergen
6) Have best-corrected visual acuity of 0.2 or better, using the landolt ring chart
7) Have a positive bilateral CAC reaction at Visit 2
8) Have a positive bilateral CAC reaction at Visit 3
9) Be willing to discontinue wearing any contact lenses
10) Provide written informed consent
Key exclusion criteria
1) Have a history of allergic hypersensitivity to any compound or chemical class related to the investigational drug being studied or its excipients used in this trial
2) Have previous participation in a clinical trial with AGN-229666
3) Have presence of any ocular condition that could affect the patient's safety or trial parameters
4) Have known history of vernal keratoconjunctivitis and/or atopic keratoconjunctivitis
5) Have had ocular surgical intervention and/or a history of refractive surgery
6) Have a known history of retinal detachment, diabetic retinopathy, or progressive retinal disease
7) Have the presence of an active ocular infection or preauricular lymphadenopathy, or positive history of an ocular herpetic infection
8) Have any uncontrolled systemic disease
9) Have history of status asthmaticus, persistent moderate or severe asthma, or moderate to severe allergic asthmatic reactions to study allergen(s)
10) Manifest signs or symptoms of clinically active allergic conjunctivitis
11) Be a female who is pregnant or nursing, or a person who is planning a pregnancy
12) Be a person not using a reliable means of contraception
13) Have a use of disallowed medications during the appropriate pre-study washout period or anticipated use during the study
14) Have a use of depot corticosteroids within 6 months or anticipated use during the study
15) Have planned surgery (ocular or systemic) during the study period or within 30 days after completion
16) Be currently enrolled in an investigational drug or device study or have had administration of investigational drug in such a study within 16 weeks of entry into this study
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Fujishima |
Organization
Tsurumi University School of Dental Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-1-3, Tsurumi, Tsurumi-ku, Yokohama-shi, Kanagawa, 230-8501 Japan
TEL
045-580-8599
fijishima117@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuro Sekiya |
Organization
Senju Pharmaceutical Co.,Ltd.
Division name
Clinical Development
Zip code
Address
6-4-3, Minatojima-Minamimachi, Chuo-Ku, Kobe, Hyogo, Japan
TEL
078-777-1018
Homepage URL
t-sekiya@senju.co.jp
Sponsor or person
Institute
Senju Pharmaceutical Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Senju Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2017 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 16 | 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
| 2017 | Year | 08 | Month | 02 | Day |
Last modified on
| 2019 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032540
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