Assessment of Alcon's Ocular Image Quantification System

Allergic Conjunctivitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282138
• Other study ID #: RDG-10-278
• Status: Completed
• Phase: Phase 4
• First received: January 20, 2011
• Last updated: December 16, 2012
• Start date: December 2010
• Est. completion date: March 2011

Study information

• Verified date: July 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No