Evaluation of 0.25% AGN-229666 ophthalmic solution compared to vehicle or olopatadine in the conjunctival allergen challenge (CAC) model of allergic conjunctivitis

Not Applicable

• Conditions: Allergic conjunctivitis

• Registration Number: JPRN-UMIN000028492
• Lead Sponsor: Senju Pharmaceutical Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ocular itching