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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025876
Receipt No. 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

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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
Email 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
Email t-sekiya@senju.co.jp

Sponsor
Institute Senju Pharmaceutical co.,ltd.
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029745

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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