AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02161146
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Arms: 5
• Actual Duration (Months): 6.5
• Patients Per Site Per Month: 36.7

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of AGN-229666 for the prevention of allergen-mediated conjunctivitis.

Condition or Disease	Intervention/Treatment	Phase
Conjunctivitis, Allergic	Drug: AGN-229666; Drug: Vehicle to AGN-229666; Drug: Olopatadine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Actual Study Start Date: Jun 4, 2014
• Actual Primary Completion Date: Dec 20, 2014
• Actual Study Completion Date: Dec 20, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AGN-229666 One drop of AGN-229666 in each eye on Days 1 and 15.	Drug: AGN-229666; One drop of AGN-229666 in the eye on Days 1 and 15.
Placebo Comparator: Vehicle One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.	Drug: Vehicle to AGN-229666; One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.
Active Comparator: Olopatadine One drop of olopatadine in each eye on Days 1 and 15.	Drug: Olopatadine; One drop of olopatadine in the eye on Days 1 and 15.; Other Names: Patanol®
Other: 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.	Drug: AGN-229666; One drop of AGN-229666 in the eye on Days 1 and 15.; Drug: Olopatadine; One drop of olopatadine in the eye on Days 1 and 15.; Other Names: Patanol®
Other: 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.	Drug: AGN-229666; One drop of AGN-229666 in the eye on Days 1 and 15.; Drug: Vehicle to AGN-229666; One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Tokyo		Japan

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

• Nakatani H, Gomes P, Bradford R, Guo Q, Safyan E, Hollander DA. Alcaftadine 0.25% versus Olopatadine 0.1% in Preventing Cedar Pollen Allergic Conjunctivitis in Japan: A Randomized Study. Ocul Immunol Inflamm. 2019;27(4):622-631. doi: 10.1080/09273948.2018.1432764. Epub 2018 Mar 15.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT02161146
• Other Study ID Numbers: 229666-006
• First Posted: Jun 11, 2014
• Last Update Posted: Apr 17, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Conjunctivitis; Conjunctivitis, Allergic; Olopatadine Hydrochloride

Study Results

Participant Flow

Arm/Group Title	AGN-229666	Vehicle	Olopatadine	AGN-229666/Olopatadine	AGN-229666/Vehicle
Arm/Group Description	One drop of AGN-229666 in each eye on Days 1 and 15.	One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.	One drop of olopatadine in each eye on Days 1 and 15.	One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.	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.
Period Title: Overall Study
STARTED	47	47	49	48	49
COMPLETED	46	43	49	45	48
NOT COMPLETED	1	4	0	3	1

Baseline Characteristics

Arm/Group Title	AGN-229666	Vehicle	Olopatadine	AGN-229666/Olopatadine	AGN-229666/Vehicle	Total
Arm/Group Description	One drop of AGN-229666 in each eye on Days 1 and 15.	One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.	One drop of olopatadine in each eye on Days 1 and 15.	One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.	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 of all reporting groups
Overall Participants	47	47	49	48	49	240
Age, Customized (participants) [Number]
20 to 30 years	22 46.8%	15 31.9%	16 32.7%	21 43.8%	20 40.8%	94 39.2%
>30 to 40 years	9 19.1%	12 25.5%	7 14.3%	7 14.6%	7 14.3%	42 17.5%
>40 years	16 34%	20 42.6%	26 53.1%	20 41.7%	22 44.9%	104 43.3%
Sex: Female, Male (Count of Participants)
Female	17 36.2%	22 46.8%	24 49%	19 39.6%	26 53.1%	108 45%
Male	30 63.8%	25 53.2%	25 51%	29 60.4%	23 46.9%	132 55%

Outcome Measures

1. Primary Outcome

Title	Ocular Itching Score
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AGN-229666	Vehicle	Olopatadine
Arm/Group Description	One drop of AGN-229666 in the eye on Days 1 and 15.	One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.	One drop of olopatadine in the eye on Days 1 and 15.
Measure Participants	144	96	97
Measure Eyes	186	136	145
Mean (Standard Deviation) [score on a scale]	0.33 (0.523)	1.48 (0.904)	0.29 (0.411)

2. Secondary Outcome

Title	Conjunctival Hyperemia Score
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AGN-229666	Vehicle	Olopatadine
Arm/Group Description	One drop of AGN-229666 in the eye on Days 1 and 15.	One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.	One drop of olopatadine in the eye on Days 1 and 15.
Measure Participants	144	96	97
Measure Eyes	186	136	145
Mean (Standard Deviation) [score on a scale]	1.15 (0.771)	1.61 (0.820)	1.34 (0.849)

Adverse Events

Arm/Group Title	AGN-229666		Vehicle		Olopatadine		AGN-229666/Olopatadine		AGN-229666/Vehicle
Arm/Group Description	One drop of AGN-229666 in each eye on Days 1 and 15.		One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.		One drop of olopatadine in each eye on Days 1 and 15.		One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.		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.
All Cause Mortality
	AGN-229666		Vehicle		Olopatadine		AGN-229666/Olopatadine		AGN-229666/Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	AGN-229666		Vehicle		Olopatadine		AGN-229666/Olopatadine		AGN-229666/Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/47 (0%)		0/47 (0%)		0/49 (0%)		0/48 (0%)		0/49 (0%)
Other (Not Including Serious) Adverse Events
	AGN-229666		Vehicle		Olopatadine		AGN-229666/Olopatadine		AGN-229666/Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/47 (8.5%)		10/47 (21.3%)		6/49 (12.2%)		3/48 (6.3%)		5/49 (10.2%)
Infections and infestations
Nasopharyngitis	3/47 (6.4%)		1/47 (2.1%)		1/49 (2%)		0/48 (0%)		2/49 (4.1%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort	1/47 (2.1%)		6/47 (12.8%)		3/49 (6.1%)		2/48 (4.2%)		1/49 (2%)
Oropharyngeal pain	1/47 (2.1%)		3/47 (6.4%)		2/49 (4.1%)		1/48 (2.1%)		2/49 (4.1%)
Rhinorrhoea	1/47 (2.1%)		3/47 (6.4%)		2/49 (4.1%)		0/48 (0%)		1/49 (2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.