NCT01282138

Assessment of Alcon's Ocular Image Quantification System

A Study to Assess Alcon's Ocular Image Quantification Using Conjunctival Allergan Provocation Testing (CAPT) and Natural Allergen Exposure in an Environmental Exposure Chamber (EEC)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate ocular responses with different allergen provocation methods.

Detailed description

Subjects demonstrating a successful allergen response to a common allergen received the first study treatment and used as instructed for 5 days, after which they entered the Environmental Exposure Chamber (EEC) for a 3-hour exposure to a known concentration of the allergen. After waiting at least 7 days, subjects received the second study treatment and used as instructed for 5 days, after which a 3-hour Conjunctival Allergen Provocation Test (CAPT) was performed with an escalating concentration of the allergen. Subjects dosed with study treatment approximately 15 minutes prior to each allergen provocation test.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)	One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.
OTHER	Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)	One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2011-01-24
• Last updated: 2012-12-18
• Results posted: 2012-07-25

Locations

1 site across 1 country: United States