AGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic Conjunctivitis
Overview
- Phase
- Phase 3
- Intervention
- AGN-229666
- Conditions
- Conjunctivitis, Allergic
- Sponsor
- Allergan
- Enrollment
- 140
- Primary Endpoint
- Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of seasonal or perennial allergic conjunctivitis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Japanese patients living in Japan with allergic conjunctivitis with itching and redness
- •Able and willing to discontinue wearing any contact lenses during the study period.
Exclusion Criteria
- •Eye surgical intervention and/or a history of refractive surgery within 6 months
- •History of retinal detachment, diabetic retinopathy, or progressive retinal disease
- •Presence of active eye infection (bacterial, viral, or fungal)
- •History of an eye herpetic infection
- •Use of corticosteroids within 6 months or anticipated use during the study.
Arms & Interventions
AGN-229666
One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
Intervention: AGN-229666
Outcomes
Primary Outcomes
Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale
Time Frame: Baseline, Day 70
Ocular itching frequency is assessed on a 6-poing scale, where 0 = did not occur, 1 = once in 3 days, 2 = twice in 3 days, 3 = once every day, 4 = 2 or more times every day, and 5 = virtually all the time over the past 3 days. Ocular itching frequency is evaluated over the 3 days prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.