UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of 0.25% AGN-229666 ophthalmic solution compared to vehicle or olopatadine in the conjunctival allergen challenge (CAC) model of allergic conjunctivitis
Title of the study (Brief title)	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	Hiroshi Fujishima
Organization	Tsurumi University School of Dental Medicine
Division name	Department of Ophthalmology
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	Takuro Sekiya
Organization	Senju Pharmaceutical Co.,Ltd.
Division name	Clinical Development
Address	6-4-3, Minatojima-Minamimachi, Chuo-Ku, Kobe, Hyogo, Japan
TEL	078-777-1018
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032540