AGN-229666 for the Treatment of Allergic Conjunctivitis
Overview
- Phase
- Phase 2
- Intervention
- AGN-229666
- Conditions
- Allergic Conjunctivitis
- Sponsor
- Allergan
- Enrollment
- 90
- Primary Endpoint
- Ocular Itching Score at Day 1
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic conjunctivitis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Japanese patients living in Japan with a history of allergic conjunctivitis
- •Willing to discontinue wearing contact lenses during the study period
Exclusion Criteria
- •Use of nicotine products during the study period
- •Presence of active eye infection (bacterial, viral, or fungal)
- •History of an ocular herpetic infection
- •Eye surgery intervention within 3 months and/or a history of refractive surgery within the past 6 months
Arms & Interventions
AGN-229666 Dose A
One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
Intervention: AGN-229666
AGN-229666 Dose B
One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
Intervention: AGN-229666
vehicle of AGN-229666
One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
Intervention: vehicle of AGN-229666
Outcomes
Primary Outcomes
Ocular Itching Score at Day 1
Time Frame: Day 1
The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (CAC) (8 hours post-dose) at Day 1 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.
Secondary Outcomes
- Ocular Itching Score at Day 15(Day 15)
- Conjunctival Hyperemia Score(Day 1)