AGN-229666 for the Treatment of Allergic Conjunctivitis

Allergic Conjunctivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754766
• Other study ID #: 229666-002
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2012
• Last updated: December 17, 2013
• Start date: October 2012
• Est. completion date: February 2013

Study information

• Verified date: December 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Japanese patients living in Japan with a history of allergic conjunctivitis

• Willing to discontinue wearing contact lenses during the study period

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• AGN-229666
One drop of AGN-229666 into each eye on Day 1 and Day 15.

Other:
• vehicle of AGN-229666
One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Itching Score at 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.	Day 1	No
Secondary	Ocular Itching Score at 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.	Day 15	No
Secondary	Conjunctival Hyperemia Score	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.	Day 1	No