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
Summary
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 HoursChange 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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 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
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