UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025876 |
|---|---|
| Receipt number | R000029745 |
| Scientific Title | Phase III long-term safety and efficacy of AGN-229666 in patients with seasonal or perennial allergic conjunctivitis |
| Date of disclosure of the study information | 2017/01/31 |
| Last modified on | 2018/07/30 09:15:22 |
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Basic information
Public title
Phase III long-term safety and efficacy of AGN-229666 in patients with seasonal or perennial allergic conjunctivitis
Acronym
A long-term safety and efficacy of AGN-229666 in patients with seasonal or perennial allergic conjunctivitis
Scientific Title
Phase III long-term safety and efficacy of AGN-229666 in patients with seasonal or perennial allergic conjunctivitis
Scientific Title:Acronym
A long-term safety and efficacy of AGN-229666 in patients with seasonal or perennial allergic conjunctivitis
Region
| Japan |
Condition
Condition
Seasonal or perennial allergic conjunctivitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of once-daily or twice-daily dosed 0.25% AGN-229666 ophthalmic solution for 10 weeks in Japanese patients with seasonal or perennial allergic conjunctivitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes from the baseline (Visit 2) in ocular itching frequency score at Visit 5 (the last visit) or at the discontinuation of treatment
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
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
0.25% AGN-229666 ophthalmic solution is instilled into each eye twice-daily (in the morning and in the evening) for 10 weeks.
Interventions/Control_2
0.25% AGN-229666 ophthalmic solution is instilled into each eye in the morning with the vehicle administered in the evening to mask against AGN-229666 for 10 weeks.
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
| 10 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Written informed consent was obtained after adequate explanation on participating the study. For minors (age < 20 years) participating in the study, informed consent was obtained from a legally authorized representative, and minor assent or informed consent was obtained from minors participating in the study
2) Japanese male or female outpatient, 10 years of age or older
3) Females of childbearing potential must have a negative blood pregnancy test at screening and must not be breastfeeding.
4) Diagnosis of seasonal or perennial allergic conjunctivitis
Key exclusion criteria
1) History of allergic hypersensitivity or known hypersensitivity to the study drug or its ingredients
2) History of vernal conjunctivitis or atopic conjunctivitis
3) History of retinal detachment or diabetic retinopathy or presence of any retinal disease that may progress
4) Presence of active ocular disease (bacterial, fungal or viral) or preauricular lymphadenopathy or a positive history of an ocular herpetic infection
5) Under hyposensitization therapy or anticipated use
6) Previously received hyposensitization therapy with negative result in the allergic test at screening
Target sample size
250
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
2-5-8, Hirano-machi, Chuo-ku, Osaka, Japan
TEL
06-6201-9630
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 | 01 | Month | 31 | 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
| 2016 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 31 | 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 | 01 | Month | 27 | Day |
Last modified on
| 2018 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029745
