AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis
Overview
- Phase
- Phase 3
- Intervention
- AGN-229666
- Conditions
- Conjunctivitis, Allergic
- Sponsor
- Allergan
- Enrollment
- 240
- Primary Endpoint
- Ocular Itching Score
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study will evaluate the safety and efficacy of AGN-229666 for the prevention of allergen-mediated conjunctivitis.
Investigators
Eligibility Criteria
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.
Arms & Interventions
AGN-229666/Olopatadine
One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
Intervention: AGN-229666
AGN-229666
One drop of AGN-229666 in each eye on Days 1 and 15.
Intervention: AGN-229666
Vehicle
One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
Intervention: Vehicle to AGN-229666
Olopatadine
One drop of olopatadine in each eye on Days 1 and 15.
Intervention: Olopatadine
AGN-229666/Olopatadine
One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
Intervention: Olopatadine
AGN-229666/Vehicle
One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
Intervention: AGN-229666
AGN-229666/Vehicle
One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
Intervention: Vehicle to AGN-229666
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Conjunctival Hyperemia Score(Days 1 and 15)