Allergic Conjunctivitis
Conditions
Brief summary
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic conjunctivitis.
Interventions
DRUGAGN-229666
One drop of AGN-229666 into each eye on Day 1 and Day 15.
OTHERvehicle of AGN-229666
One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching Score at Day 1 | 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
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching Score at Day 15 | Day 15 | The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (16 hours post-dose) at Day 15 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. |
| Conjunctival Hyperemia Score | Day 1 | Conjunctival hyperemia is the engorgement of the blood vessels (redness) of the clear membrane covering the white surface of the eye. Conjunctival hyperemia was evaluated 15 minutes post conjunctival allergen challenge (CAC) (8 hours post dose) on Day 1 for both eyes using a 9-point scale in half-unit increments where: 0=none to 4=Extremely severe. The score for each participant was the average of the score of both eyes. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AGN-229666 Dose A One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15. | 31 |
| AGN-229666 Dose B One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15. | 29 |
| Vehicle of AGN-229666 One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15. | 30 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Personal reasons | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | AGN-229666 Dose A | AGN-229666 Dose B | Vehicle of AGN-229666 | Total |
|---|---|---|---|---|
| Age, Customized 20-30 years | 11 Participants | 7 Participants | 4 Participants | 22 Participants |
| Age, Customized >30-40 years | 7 Participants | 7 Participants | 10 Participants | 24 Participants |
| Age, Customized >40 years | 13 Participants | 15 Participants | 16 Participants | 44 Participants |
| Sex: Female, Male Female | 14 Participants | 15 Participants | 15 Participants | 44 Participants |
| Sex: Female, Male Male | 17 Participants | 14 Participants | 15 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 2 / 29 | 0 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 29 | 0 / 30 |
Outcome results
Primary
Ocular Itching Score at 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.
Time frame: Day 1
Population: Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AGN-229666 Dose A | Ocular Itching Score at Day 1 | 0.500 Score on a scale | Standard Deviation 0.5123 |
| AGN-229666 Dose B | Ocular Itching Score at Day 1 | 0.319 Score on a scale | Standard Deviation 0.3947 |
| Vehicle of AGN-229666 | Ocular Itching Score at Day 1 | 1.867 Score on a scale | Standard Deviation 0.9485 |
Secondary
Conjunctival Hyperemia Score
Conjunctival hyperemia is the engorgement of the blood vessels (redness) of the clear membrane covering the white surface of the eye. Conjunctival hyperemia was evaluated 15 minutes post conjunctival allergen challenge (CAC) (8 hours post dose) on Day 1 for both eyes using a 9-point scale in half-unit increments where: 0=none to 4=Extremely severe. The score for each participant was the average of the score of both eyes.
Time frame: Day 1
Population: Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AGN-229666 Dose A | Conjunctival Hyperemia Score | 1.387 Score on a scale | Standard Deviation 0.6118 |
| AGN-229666 Dose B | Conjunctival Hyperemia Score | 1.345 Score on a scale | Standard Deviation 1.0531 |
| Vehicle of AGN-229666 | Conjunctival Hyperemia Score | 1.633 Score on a scale | Standard Deviation 0.5972 |
Secondary
Ocular Itching Score at Day 15
The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (16 hours post-dose) at Day 15 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.
Time frame: Day 15
Population: Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AGN-229666 Dose A | Ocular Itching Score at Day 15 | 0.358 Score on a scale | Standard Deviation 0.4083 |
| AGN-229666 Dose B | Ocular Itching Score at Day 15 | 0.214 Score on a scale | Standard Deviation 0.3582 |
| Vehicle of AGN-229666 | Ocular Itching Score at Day 15 | 1.258 Score on a scale | Standard Deviation 0.9249 |