Trial Outcomes & Findings for AGN-229666 for the Treatment of Allergic Conjunctivitis (NCT NCT01754766)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

90 participants

Primary outcome timeframe

Day 1

Results posted on

2014-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	AGN-229666 Dose A One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.	AGN-229666 Dose B One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.	Vehicle of AGN-229666 One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
Overall Study STARTED	31	29	30
Overall Study COMPLETED	30	28	30
Overall Study NOT COMPLETED	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	AGN-229666 Dose A One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.	AGN-229666 Dose B One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.	Vehicle of AGN-229666 One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
Overall Study Personal reasons	1	1	0

Baseline Characteristics

AGN-229666 for the Treatment of Allergic Conjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AGN-229666 Dose A n=31 Participants One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.	AGN-229666 Dose B n=29 Participants One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.	Vehicle of AGN-229666 n=30 Participants One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.	Total n=90 Participants Total of all reporting groups
Age, Customized 20-30 years	11 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	22 Participants n=4 Participants
Age, Customized >30-40 years	7 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	24 Participants n=4 Participants
Age, Customized >40 years	13 Participants n=5 Participants	15 Participants n=7 Participants	16 Participants n=5 Participants	44 Participants n=4 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	44 Participants n=4 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants	46 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point

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.

Outcome measures

Outcome measures
Measure	AGN-229666 Dose A n=31 Participants One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.	AGN-229666 Dose B n=29 Participants One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.	Vehicle of AGN-229666 n=30 Participants One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
Ocular Itching Score at Day 1	0.500 Score on a scale Standard Deviation 0.5123	0.319 Score on a scale Standard Deviation 0.3947	1.867 Score on a scale Standard Deviation 0.9485

SECONDARY outcome

Timeframe: Day 15

Population: Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point

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.

Outcome measures

Outcome measures
Measure	AGN-229666 Dose A n=30 Participants One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.	AGN-229666 Dose B n=28 Participants One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.	Vehicle of AGN-229666 n=30 Participants One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
Ocular Itching Score at Day 15	0.358 Score on a scale Standard Deviation 0.4083	0.214 Score on a scale Standard Deviation 0.3582	1.258 Score on a scale Standard Deviation 0.9249

SECONDARY outcome

Timeframe: Day 1

Population: Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point

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.

Outcome measures

Outcome measures
Measure	AGN-229666 Dose A n=31 Participants One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.	AGN-229666 Dose B n=29 Participants One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.	Vehicle of AGN-229666 n=30 Participants One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
Conjunctival Hyperemia Score	1.387 Score on a scale Standard Deviation 0.6118	1.345 Score on a scale Standard Deviation 1.0531	1.633 Score on a scale Standard Deviation 0.5972

Adverse Events

AGN-229666 Dose A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AGN-229666 Dose B

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Vehicle of AGN-229666

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	AGN-229666 Dose A n=31 participants at risk One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.	AGN-229666 Dose B n=29 participants at risk One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.	Vehicle of AGN-229666 n=30 participants at risk One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
Eye disorders Ocular hyperaemia	0.00% 0/31	6.9% 2/29	0.00% 0/30

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER