DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Assessment of Alcon's Ocular Image Quantification System

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Allergic Conjunctivitis

Intervention: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol) (Drug); Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II) (Other)

Phase: Phase 4

Status: Completed

Sponsored by: Alcon Research


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

Clinical Details

Official 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)

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Primary outcome:

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

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

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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


- Other protocol-defined exclusion criteria may apply.

Locations and Contacts

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

Starting date: December 2010
Last updated: December 16, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017