Conjunctivitis, Allergic
Conditions
Brief summary
This study will evaluate the safety and efficacy of AGN-229666 for the prevention of allergen-mediated conjunctivitis.
Interventions
DRUGAGN-229666
One drop of AGN-229666 in the eye on Days 1 and 15.
DRUGVehicle to AGN-229666
One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.
DRUGOlopatadine
One drop of olopatadine in the eye on Days 1 and 15.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
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.
Exclusion criteria
* Presence of active eye infection (bacterial, viral, or fungal) * History of an eye herpetic infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching Score | Days 1 and 15 | Ocular itching was assessed by the participant 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 5 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no itching) to 4.0=incapacitating itch with an irresistible urge to rub (worst). Data from Days 1 and 15 were pooled together and averaged. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conjunctival Hyperemia Score | Days 1 and 15 | Hyperemia is the engorgement of the blood vessels (redness) of the eye. Ocular hyperemia was evaluated by the investigator 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 15 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no hyperemia) to 4.0=extremely severe (large, numerous dilated blood vessels characterized by severe deep red color). Data from Days 1 and 15 were pooled together and averaged. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AGN-229666 One drop of AGN-229666 in each eye on Days 1 and 15. | 47 |
| Vehicle One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15. | 47 |
| Olopatadine One drop of olopatadine in each eye on Days 1 and 15. | 49 |
| AGN-229666/Olopatadine One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15. | 48 |
| AGN-229666/Vehicle One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15. | 49 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Other Miscellaneous Reasons | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Personal Reasons | 0 | 1 | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | AGN-229666 | Vehicle | Olopatadine | AGN-229666/Olopatadine | AGN-229666/Vehicle | Total |
|---|---|---|---|---|---|---|
| Age, Customized 20 to 30 years | 22 participants | 15 participants | 16 participants | 21 participants | 20 participants | 94 participants |
| Age, Customized >30 to 40 years | 9 participants | 12 participants | 7 participants | 7 participants | 7 participants | 42 participants |
| Age, Customized >40 years | 16 participants | 20 participants | 26 participants | 20 participants | 22 participants | 104 participants |
| Sex: Female, Male Female | 17 Participants | 22 Participants | 24 Participants | 19 Participants | 26 Participants | 108 Participants |
| Sex: Female, Male Male | 30 Participants | 25 Participants | 25 Participants | 29 Participants | 23 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 47 | 10 / 47 | 6 / 49 | 3 / 48 | 5 / 49 |
| serious Total, serious adverse events | 0 / 47 | 0 / 47 | 0 / 49 | 0 / 48 | 0 / 49 |
Outcome results
Primary
Ocular Itching Score
Ocular itching was assessed by the participant 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 5 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no itching) to 4.0=incapacitating itch with an irresistible urge to rub (worst). Data from Days 1 and 15 were pooled together and averaged.
Time frame: Days 1 and 15
Population: Participants from the Intent-to-Treat Population, all randomized participants, with data of treated eyes available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AGN-229666 | Ocular Itching Score | 0.33 score on a scale | Standard Deviation 0.523 |
| Vehicle | Ocular Itching Score | 1.48 score on a scale | Standard Deviation 0.904 |
| Olopatadine | Ocular Itching Score | 0.29 score on a scale | Standard Deviation 0.411 |
Secondary
Conjunctival Hyperemia Score
Hyperemia is the engorgement of the blood vessels (redness) of the eye. Ocular hyperemia was evaluated by the investigator 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 15 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no hyperemia) to 4.0=extremely severe (large, numerous dilated blood vessels characterized by severe deep red color). Data from Days 1 and 15 were pooled together and averaged.
Time frame: Days 1 and 15
Population: Participants from the Intent-to-Treat Population, all randomized participants, with data of treated eyes available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AGN-229666 | Conjunctival Hyperemia Score | 1.15 score on a scale | Standard Deviation 0.771 |
| Vehicle | Conjunctival Hyperemia Score | 1.61 score on a scale | Standard Deviation 0.82 |
| Olopatadine | Conjunctival Hyperemia Score | 1.34 score on a scale | Standard Deviation 0.849 |