AGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic Conjunctivitis

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02082262
• Collaborator: (none)
• Enrollment: 140
• Location: 1
• Arm: 1
• Duration (Months): 4
• Patients Per Site Per Month: 34.9

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of AGN-229666 for the treatment of seasonal or perennial allergic conjunctivitis.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 140 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AGN-229666 One to two drops of AGN-229666 twice daily in each eye for 10 weeks.	Drug: AGN-229666; One to two drops of AGN-229666 twice daily in each eye for 10 weeks.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale [Baseline, Day 70]

   Ocular itching frequency is assessed on a 6-poing scale, where 0 = did not occur, 1 = once in 3 days, 2 = twice in 3 days, 3 = once every day, 4 = 2 or more times every day, and 5 = virtually all the time over the past 3 days. Ocular itching frequency is evaluated over the 3 days prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Japanese patients living in Japan with allergic conjunctivitis with itching and redness

• Able and willing to discontinue wearing any contact lenses during the study period.

Exclusion Criteria:

• Eye surgical intervention and/or a history of refractive surgery within 6 months

• History of retinal detachment, diabetic retinopathy, or progressive retinal disease

• Presence of active eye infection (bacterial, viral, or fungal)

• History of an eye herpetic infection

• Use of corticosteroids within 6 months or anticipated use during the study.

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

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT02082262
• Other Study ID Numbers: 229666-005
• First Posted: Mar 10, 2014
• Last Update Posted: Mar 14, 2016
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Conjunctivitis; Conjunctivitis, Allergic

Study Results

Participant Flow

Arm/Group Title	AGN-229666
Arm/Group Description	One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
Period Title: Overall Study
STARTED	140
COMPLETED	89
NOT COMPLETED	51

Baseline Characteristics

Arm/Group Title	AGN-229666
Arm/Group Description	One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
Overall Participants	140
Age, Customized (Number) [Number]
≥ 10 to < 20 years	38 27.1%
≥ 20 to < 40 years	44 31.4%
≥ 40 years	58 41.4%
Sex: Female, Male (Count of Participants)
Female	82 58.6%
Male	58 41.4%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale
Description	Ocular itching frequency is assessed on a 6-poing scale, where 0 = did not occur, 1 = once in 3 days, 2 = twice in 3 days, 3 = once every day, 4 = 2 or more times every day, and 5 = virtually all the time over the past 3 days. Ocular itching frequency is evaluated over the 3 days prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Time Frame	Baseline, Day 70

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat: all enrolled patients with at least one follow-up ocular itching frequency score

Arm/Group Title	AGN-229666
Arm/Group Description	One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
Measure Participants	140
Baseline	4.4 (0.49)
Change from Baseline at Day 70 (N=110)	-3.4 (1.51)

Adverse Events

Arm/Group Title	AGN-229666
Arm/Group Description	One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
All Cause Mortality
	AGN-229666
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	AGN-229666
	Affected / at Risk (%)	# Events
Total	0/140 (0%)
Other (Not Including Serious) Adverse Events
	AGN-229666
	Affected / at Risk (%)	# Events
Total	96/140 (68.6%)
Eye disorders
Conjunctival Hyperaemia	48/140 (34.3%)
Eye Pruritus	28/140 (20%)
Eye Discharge	14/140 (10%)
Ciliary Hyperaemia	11/140 (7.9%)
Eyelid Oedema	9/140 (6.4%)
Blepharitis	8/140 (5.7%)
Conjunctivitis	8/140 (5.7%)
Conjunctival Oedema	7/140 (5%)
General disorders
Instillation Site Irritation	12/140 (8.6%)
Infections and infestations
Nasopharyngitis	7/140 (5%)
Nervous system disorders
Somnolence	26/140 (18.6%)

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.