Assessment of Alcon's Ocular Image Quantification System

Alcon Research13 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Allergic Conjunctivitis

Interventions

Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)DRUG

One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.

Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)OTHER

One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 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.

Time frame: Baseline, 3 hours

Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 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.

Time frame: Baseline, 3 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.