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Completed

NCT Number: NCT01282138

Assessment of Alcon's Ocular Image Quantification System

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

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Patanol®

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.

Other names: Tears Naturale II

Primary outcomes

  1. Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours

    Time frame: 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.

  2. Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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)

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 24, 2011
Registry last updated
Dec 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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