Trial Outcomes & Findings for AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis (NCT NCT02161146)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

240 participants

Primary outcome timeframe

Days 1 and 15

Results posted on

2019-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	AGN-229666 One drop of AGN-229666 in each eye on Days 1 and 15.	Vehicle One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.	Olopatadine One drop of olopatadine in each eye on Days 1 and 15.	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.	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.
Overall Study STARTED	47	47	49	48	49
Overall Study COMPLETED	46	43	49	45	48
Overall Study NOT COMPLETED	1	4	0	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	AGN-229666 One drop of AGN-229666 in each eye on Days 1 and 15.	Vehicle One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.	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.	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.
Overall Study Adverse Event	1	1	1	0
Overall Study Lost to Follow-up	0	1	0	0
Overall Study Personal Reasons	0	1	2	1
Overall Study Other Miscellaneous Reasons	0	1	0	0

Baseline Characteristics

AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AGN-229666 n=47 Participants One drop of AGN-229666 in each eye on Days 1 and 15.	Vehicle n=47 Participants One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.	Olopatadine n=49 Participants One drop of olopatadine in each eye on Days 1 and 15.	AGN-229666/Olopatadine n=48 Participants One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.	AGN-229666/Vehicle n=49 Participants 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.	Total n=240 Participants Total of all reporting groups
Age, Customized 20 to 30 years	22 participants n=5 Participants	15 participants n=7 Participants	16 participants n=5 Participants	21 participants n=4 Participants	20 participants n=21 Participants	94 participants n=8 Participants
Age, Customized >30 to 40 years	9 participants n=5 Participants	12 participants n=7 Participants	7 participants n=5 Participants	7 participants n=4 Participants	7 participants n=21 Participants	42 participants n=8 Participants
Age, Customized >40 years	16 participants n=5 Participants	20 participants n=7 Participants	26 participants n=5 Participants	20 participants n=4 Participants	22 participants n=21 Participants	104 participants n=8 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	22 Participants n=7 Participants	24 Participants n=5 Participants	19 Participants n=4 Participants	26 Participants n=21 Participants	108 Participants n=8 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants	29 Participants n=4 Participants	23 Participants n=21 Participants	132 Participants n=8 Participants

PRIMARY outcome

Timeframe: Days 1 and 15

Population: Participants from the Intent-to-Treat Population, all randomized participants, with data of treated eyes available for analysis.

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.

Outcome measures

Outcome measures
Measure	AGN-229666 n=186 Eyes One drop of AGN-229666 in the eye on Days 1 and 15.	Vehicle n=136 Eyes One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.	Olopatadine n=145 Eyes One drop of olopatadine in the eye on Days 1 and 15.
Ocular Itching Score	0.33 score on a scale Standard Deviation 0.523	1.48 score on a scale Standard Deviation 0.904	0.29 score on a scale Standard Deviation 0.411

SECONDARY outcome

Timeframe: Days 1 and 15

Population: Participants from the Intent-to-Treat Population, all randomized participants, with data of treated eyes available for analysis.

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.