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Phase III long-term safety and efficacy of AGN-229666 in patients with seasonal or perennial allergic conjunctivitis

Phase III long-term safety and efficacy of AGN-229666 in patients with seasonal or perennial allergic conjunctivitis - A long-term safety and efficacy of AGN-229666 in patients with seasonal or perennial allergic conjunctivitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025876
Enrollment
250
Registered
2017-01-31
Start date
2017-01-31
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal or perennial allergic conjunctivitis

Interventions

0.25% AGN-229666 ophthalmic solution is instilled into each eye twice-daily (in the morning and in the evening) for 10 weeks. 0.25% AGN-229666 ophthalmic solution is instilled into each eye in the mor

Sponsors

Senju Pharmaceutical co.,ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Changes from the baseline (Visit 2) in ocular itching frequency score at Visit 5 (the last visit) or at the discontinuation of treatment

Countries

Japan

Contacts

Public ContactTakuro Sekiya

Senju Pharmaceutical co.,ltd. Clinical Development

t-sekiya@senju.co.jp06-6201-9630

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026