Allergic Conjunctivitis Clinical Trial
Verified date | December 2013 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
Study type | Interventional |
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic conjunctivitis.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Allergan |
Japan,
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 |
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