Clinical Trial: AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

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

Detailed Summary:
Sponsor: Allergan

Current Primary Outcome: Ocular Itching Score [ Time Frame: Days 1 and 15 ]

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.


Original Primary Outcome: Ocular Itching Score Using a 6-Point Scale [ Time Frame: Day 15 ]

Current Secondary Outcome: Conjunctival Hyperemia Score [ Time Frame: Days 1 and 15 ]

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.


Original Secondary Outcome: Conjunctival Hyperemia Score Using a 9-Point Scale [ Time Frame: Day 15 ]

Information By: Allergan

Dates:
Date Received: June 9, 2014
Date Started: June 2014
Date Completion:
Last Updated: February 8, 2016
Last Verified: February 2016