Back to resultsAssessment of Alcon's Ocular Image Quantification System
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)
Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)
Sponsored by
About this trial
This is an interventional diagnostic trial for Allergic Conjunctivitis focused on measuring Allergic conjunctivitis
Eligibility 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.
Sites / Locations
- Contact Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Patanol
Tears Naturale II
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01282138
Brief Title
Assessment of Alcon's Ocular Image Quantification System
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 Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to evaluate ocular responses with different allergen provocation methods.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
Allergic conjunctivitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patanol
Arm Type
Experimental
Arm Description
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.
Arm Title
Tears Naturale II
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)
Other Intervention Name(s)
Patanol®
Intervention Description
One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.
Intervention Type
Other
Intervention Name(s)
Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)
Other Intervention Name(s)
Tears Naturale II
Intervention Description
One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.
Primary Outcome Measure Information:
Title
Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours
Description
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.
Time Frame
Baseline, 3 hours
Title
Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours
Description
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.
Time Frame
Baseline, 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assessment of Alcon's Ocular Image Quantification System
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