AGN-229666 for the Treatment of Allergic Conjunctivitis

Phase 2

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: AGN-229666; Other: vehicle of AGN-229666

• Registration Number: NCT01754766
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-12-19
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-21
• Primary Completion: 2013-01
• Study Completion: 2013-02
• Status Verified: 2013-12
• Results First Submitted: 2013-12-17
• Results First Submitted QC: 2013-12-17
• Last Update Submitted: 2013-12-17
• Results First Posted: 2014-02-04
• Last Update Posted: 2014-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Japanese patients living in Japan with a history of allergic conjunctivitis
• Willing to discontinue wearing contact lenses during the study period

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Exclusion Criteria

• Use of nicotine products during the study period
• Presence of active eye infection (bacterial, viral, or fungal)
• History of an ocular herpetic infection
• Eye surgery intervention within 3 months and/or a history of refractive surgery within the past 6 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AGN-229666 Dose A	AGN-229666	One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
AGN-229666 Dose B	AGN-229666	One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
vehicle of AGN-229666	vehicle of AGN-229666	One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.

Primary Outcome Measures

Name	Time	Method
Ocular Itching Score at Day 1	Day 1	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.

Secondary Outcome Measures

Name	Time	Method
Ocular Itching Score at Day 15	Day 15	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.
Conjunctival Hyperemia Score	Day 1	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.