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)

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

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 Names: Patanol®
Placebo Comparator: 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.	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.; Other Names: Tears Naturale II

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, 3 hours

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: January 20, 2011
• First Submitted That Met QC Criteria: January 21, 2011
• First Posted (Estimate): January 24, 2011

Study Record Updates

• Last Update Posted (Estimate): December 18, 2012
• Last Update Submitted That Met QC Criteria: December 16, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Allergic conjunctivitis
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Anticoagulants; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Pharmaceutical Solutions; Histamine H1 Antagonists, Non-Sedating; Plasma Substitutes; Blood Substitutes; Ophthalmic Solutions; Dextrans; Olopatadine Hydrochloride
• Other Study ID Numbers: RDG-10-278