Phase 3
N=140
AGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic Conjunctivitis
Conjunctivitis, Allergic
Bottom Line
View on ClinicalTrials.gov: NCT02082262 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale — 4.4; -3.4 Scores on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AGN-229666 (Drug)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale |
4.4; -3.4 | — |
Summary
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of seasonal or perennial allergic conjunctivitis.
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.
Data sourced from ClinicalTrials.gov (NCT02082262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.