Assessment of Alcon's Ocular Image Quantification System
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)
1 other identifier
interventional
13
1 country
1
Brief Summary
The purpose of this study was to evaluate ocular responses with different allergen provocation methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 20, 2011
CompletedFirst Posted
Study publicly available on registry
January 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
July 25, 2012
CompletedDecember 18, 2012
July 1, 2012
3 months
January 20, 2011
June 20, 2012
December 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
Patanol
EXPERIMENTALOne 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.
Tears Naturale II
PLACEBO COMPARATOROne 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.
Interventions
One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.
One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.
Eligibility Criteria
You may qualify if:
- History of allergic conjunctivitis;
- Active signs and symptoms of ocular allergies;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This was a pilot study with a small number of subjects not adequately powered to detect treatment differences.
Results Point of Contact
- Title
- Head, Global Medical Affairs
- Organization
- Alcon Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2011
First Posted
January 24, 2011
Study Start
December 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
December 18, 2012
Results First Posted
July 25, 2012
Record last verified: 2012-07