Assessment of Alcon's Ocular Image Quantification System

Phase 4

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol); Other: Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)

• Registration Number: NCT01282138
• Lead Sponsor: Alcon Research

Brief 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-01-21
• Study First Posted: 2011-01-24
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2012-06-20
• Results First Submitted QC: 2012-06-20
• Status Verified: 2012-07
• Results First Posted: 2012-07-25
• Last Update Submitted: 2012-12-16
• Last Update Posted: 2012-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• History of allergic conjunctivitis;
• Active signs and symptoms of ocular allergies;
• Other protocol-defined inclusion criteria may apply.

Read More

Exclusion Criteria

• History of dry eye;
• Presence of ocular infection;
• Presence of severe or serious ocular conditions;
• Symptoms of allergic conjunctivitis;
• Use of topical or systemic ocular medications as specified in protocol;
• Ocular surgery or laser surgery within 6 months of study start;
• Unwilling to discontinue contact lens wear 72 hours prior to Visit 1 and during study period;
• Other protocol-defined exclusion criteria may apply.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patanol	Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)	One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
Tears Naturale II	Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)	One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours	Baseline, 3 hours	As assessed by the participant after 3 hours in the EEC. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.
Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours	Baseline, 3 hours	As assessed by the participant after 3 hours of CAPT. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States