AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis

Conjunctivitis, Allergic Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161146
• Other study ID #: 229666-006
• Status: Completed
• Phase: Phase 3
• Start date: June 4, 2014
• Est. completion date: December 20, 2014

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of AGN-229666 for the prevention of allergen-mediated conjunctivitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 20, 2014
• Est. primary completion date: December 20, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

-Japanese patients living in Japan with a history of allergic conjunctivitis.

Exclusion Criteria:

• Presence of active eye infection (bacterial, viral, or fungal)

• History of an eye herpetic infection.

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• AGN-229666
One drop of AGN-229666 in the eye on Days 1 and 15.
• Vehicle to AGN-229666
One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.
• Olopatadine
One drop of olopatadine in the eye on Days 1 and 15.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Nakatani H, Gomes P, Bradford R, Guo Q, Safyan E, Hollander DA. Alcaftadine 0.25% versus Olopatadine 0.1% in Preventing Cedar Pollen Allergic Conjunctivitis in Japan: A Randomized Study. Ocul Immunol Inflamm. 2018 Mar 15:1-10. doi: 10.1080/09273948.2018.1432764. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Itching Score	Ocular itching was assessed by the participant 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 5 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no itching) to 4.0=incapacitating itch with an irresistible urge to rub (worst). Data from Days 1 and 15 were pooled together and averaged.	Days 1 and 15
Secondary	Conjunctival Hyperemia Score	Hyperemia is the engorgement of the blood vessels (redness) of the eye. Ocular hyperemia was evaluated by the investigator 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 15 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no hyperemia) to 4.0=extremely severe (large, numerous dilated blood vessels characterized by severe deep red color). Data from Days 1 and 15 were pooled together and averaged.	Days 1 and 15