Conjunctivitis, Allergic
Conditions
Brief summary
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of seasonal or perennial allergic conjunctivitis.
Interventions
DRUGAGN-229666
One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AGN-229666 One to two drops of AGN-229666 twice daily in each eye for 10 weeks. | 140 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 48 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | AGN-229666 |
|---|---|
| Age, Customized ≥ 10 to < 20 years | 38 Participants |
| Age, Customized ≥ 20 to < 40 years | 44 Participants |
| Age, Customized ≥ 40 years | 58 Participants |
| Sex: Female, Male Female | 82 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 96 / 140 |
| serious Total, serious adverse events | 0 / 140 |
Outcome results
Primary
Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale
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.
Time frame: Baseline, Day 70
Population: Modified Intent-to-Treat: all enrolled patients with at least one follow-up ocular itching frequency score
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AGN-229666 | Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale | Baseline | 4.4 Scores on a Scale | Standard Deviation 0.49 |
| AGN-229666 | Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale | Change from Baseline at Day 70 (N=110) | -3.4 Scores on a Scale | Standard Deviation 1.51 |